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(c) Robin Inizan – Lucas Pavy Production
Tearing line by ANDRITZ in operation at the Renaissance Textile plant
11.11.2022

Renaissance Textile starts up the first textile recycling line by ANDRITZ in France

Renaissance Textile in Laval, France has successfully started up a complete textile recycling line, delivered, installed, and commissioned by ANDRITZ Laroche, part of the international technology group ANDRITZ.

The ANDRITZ textile recycling equipment enabled Renaissance Textile to become the first French recycling platform dedicated to industrial end-of-life textiles. The project aims to produce new fibers from the collected post-consumer apparel, which will be used to weave new recycled fabrics in the end.

The new 12,000 m² plant is equipped with a complete tearing line whose design is the result of close collaboration between R&D specialists from ANDRITZ Laroche and Renaissance Textile, as well as customized trials carried out jointly by the two parties at the ANDRITZ technical center in Cours, France.

Renaissance Textile in Laval, France has successfully started up a complete textile recycling line, delivered, installed, and commissioned by ANDRITZ Laroche, part of the international technology group ANDRITZ.

The ANDRITZ textile recycling equipment enabled Renaissance Textile to become the first French recycling platform dedicated to industrial end-of-life textiles. The project aims to produce new fibers from the collected post-consumer apparel, which will be used to weave new recycled fabrics in the end.

The new 12,000 m² plant is equipped with a complete tearing line whose design is the result of close collaboration between R&D specialists from ANDRITZ Laroche and Renaissance Textile, as well as customized trials carried out jointly by the two parties at the ANDRITZ technical center in Cours, France.

The new clothing produced based on this type of circular economy model thus reflects the social and sustainability commitments of Renaissance Textile in terms of decarbonizing the textile industry, the fight against global warming, autonomy in raw material sourcing, and promotion of local staffing, particularly for people who have been unemployed for a long time or are seeking to enter the labor market for the first time. By 2025, for example, Renaissance Textile plans to create no less than 110 direct jobs.

08.11.2022

MUNICH FABRIC START gibt neue Termine für 2023 bekannt

Die MUNICH FABRIC START Exhibitions GmbH verlegt die Termine für ihre internationalen Fabric Trade Shows. Ab 2023 werden die Sommerausgaben von MUNICH FABRIC START, BLUEZONE, KEYHOUSE und THE SOURCE in der zweiten Julihälfte (18. und 19. Juli 2023) stattfinden. Die VIEW wird im kommenden Sommer erstmalig als reVIEW Konzept am 5. und 6. September 2023 nach der MUNICH FABRIC START veranstaltet. Die Messetermine für Spring.Summer 24 bleiben unverändert: VIEW (29. – 30. November 2022), MUNICH FABRIC START (24. – 26. Januar 2023), BLUEZONE und KEYHOUSE (24. – 25. Januar 2023).

Die jüngste Ausgabe der Messen der Munich Fabric Start Exhibitions GmbH vom 30. August bis 1. September 2022 feierte nicht nur das Comeback von MUNICH FABRIC START und der internationalen Denim Tradeshow BLUEZONE nach den Corona-bedingt angepassten Formaten der vergangenen Saisons, sondern markierte auch das 50. Jubiläum einer der wichtigsten europäischen Stoffmessen und Business-Plattformen für die Fashion- und Denim-Branche. Insgesamt begrüßten 900 Aussteller:innen aus 40 Ländern über 14.000 Besucher:innen und zeigten ca. 1.500 Kollektionen

Die MUNICH FABRIC START Exhibitions GmbH verlegt die Termine für ihre internationalen Fabric Trade Shows. Ab 2023 werden die Sommerausgaben von MUNICH FABRIC START, BLUEZONE, KEYHOUSE und THE SOURCE in der zweiten Julihälfte (18. und 19. Juli 2023) stattfinden. Die VIEW wird im kommenden Sommer erstmalig als reVIEW Konzept am 5. und 6. September 2023 nach der MUNICH FABRIC START veranstaltet. Die Messetermine für Spring.Summer 24 bleiben unverändert: VIEW (29. – 30. November 2022), MUNICH FABRIC START (24. – 26. Januar 2023), BLUEZONE und KEYHOUSE (24. – 25. Januar 2023).

Die jüngste Ausgabe der Messen der Munich Fabric Start Exhibitions GmbH vom 30. August bis 1. September 2022 feierte nicht nur das Comeback von MUNICH FABRIC START und der internationalen Denim Tradeshow BLUEZONE nach den Corona-bedingt angepassten Formaten der vergangenen Saisons, sondern markierte auch das 50. Jubiläum einer der wichtigsten europäischen Stoffmessen und Business-Plattformen für die Fashion- und Denim-Branche. Insgesamt begrüßten 900 Aussteller:innen aus 40 Ländern über 14.000 Besucher:innen und zeigten ca. 1.500 Kollektionen

Source:

MUNICHFABRICSTART Exhibitions GmbH

08.11.2022

Ascend buys majority stake in recycler Circular Polymers

Ascend Performance Materials has purchased a majority stake in California-based Circular Polymers, a recycler of post-consumer, high-performance polymers including polyamide 6 and 66, polypropylene and polyester (PET). The deal provides Ascend with a consistent supply of high-quality PCR materials for its ReDefyne™ sustainable polyamides, launched at K 2022.

Circular Polymers, which as part of the deal is renamed Circular Polymers by Ascend, reclaims and processes post-consumer carpet via a unique technology and has redirected approximately 85 million pounds of waste from landfills into new goods since 2018.

“We are focused on helping our customers reach their sustainability goals and Circular Polymers by Ascend provides materials that offer strong performance with a considerably smaller environmental footprint, compared to other technologies like pyrolysis,” said Phil McDivitt, president and CEO of Ascend. “Since we launched ReDefyne, the demand for our circular products has been significant across all segments of our business, including automotive, consumer, electronics and high-performance fibers and textiles.”

Ascend Performance Materials has purchased a majority stake in California-based Circular Polymers, a recycler of post-consumer, high-performance polymers including polyamide 6 and 66, polypropylene and polyester (PET). The deal provides Ascend with a consistent supply of high-quality PCR materials for its ReDefyne™ sustainable polyamides, launched at K 2022.

Circular Polymers, which as part of the deal is renamed Circular Polymers by Ascend, reclaims and processes post-consumer carpet via a unique technology and has redirected approximately 85 million pounds of waste from landfills into new goods since 2018.

“We are focused on helping our customers reach their sustainability goals and Circular Polymers by Ascend provides materials that offer strong performance with a considerably smaller environmental footprint, compared to other technologies like pyrolysis,” said Phil McDivitt, president and CEO of Ascend. “Since we launched ReDefyne, the demand for our circular products has been significant across all segments of our business, including automotive, consumer, electronics and high-performance fibers and textiles.”

Ascend has a sustainability strategy based on three pillars: empowering people, innovating solutions and operating without compromise. Ascend has committed to reducing its greenhouse gas emissions by 80% by 2030 and recently announced two new efforts to reduce the carbon footprint of its products.

Source:

Ascend Performance Materials / EMG

(c) JIAM, Messe Frankfurt Japan Ltd
07.11.2022

JIAM 2022 OSAKA taking place after a six year break

JIAM 2022 OSAKA, organised by the Japan Sewing Machinery Manufacturers Association (JASMA), will soon be held at INTEX OSAKA from 30 November – 3 December 2022. Under the theme of “It all connects at JIAM – the forefront of technology and master craftsmanship”, the 12th edition brings together leading sewing machine suppliers and apparel manufacturers, making it a must-attend event for textile professionals. In this era of change, an international platform to facilitate business and information exchange is essential. The 2022 edition will showcase apparel manufacturing solutions catered to each and every need, combining high-level skillsets and time-tested knowledge with the latest modern-day technology.

JIAM 2022 OSAKA, organised by the Japan Sewing Machinery Manufacturers Association (JASMA), will soon be held at INTEX OSAKA from 30 November – 3 December 2022. Under the theme of “It all connects at JIAM – the forefront of technology and master craftsmanship”, the 12th edition brings together leading sewing machine suppliers and apparel manufacturers, making it a must-attend event for textile professionals. In this era of change, an international platform to facilitate business and information exchange is essential. The 2022 edition will showcase apparel manufacturing solutions catered to each and every need, combining high-level skillsets and time-tested knowledge with the latest modern-day technology.

As of October, 144 exhibitors from 10 countries and regions (China, Greece, Germany, Hong Kong, India, Italy, Singapore, Taiwan and Thailand) have signed up for JIAM 2022 OSAKA to showcase their latest products and services. Of these, 39 companies (21 domestic, 18 overseas) will be joining the fair for the first time. In addition, two pavilions from Germany (VDMA; Mechanical Engineering Industry Association) and Taiwan (TSMA; Taiwan Sewing Machinery Association) will bring even more product diversity to the show floor. The previous edition of JIAM OSAKA in 2016 welcomed 258 exhibitors from 15 countries and regions as well as 15,257 visitors from 72 countries and regions, mainly from Bangladesh, China, India, Korea, Taiwan, Sri Lanka, and Vietnam.

A wide variety of special seminars
11 special organiser seminars will not only provide relevant industry knowledge, but also offer practical skills for daily work:

  • Manufacturing industry and digital technology
    Mr Atsushi Yasuda, Manager of Ministry of Economy, Trade and Industry Manufacturing Industries Bureau,Industrial Machinery Division
  • Skills training seminar
    1. Twist Jacket (Lapel) pattern and matching sewing (front and shoulder seams)
    2. Shoulder keeper (prevent shoulder collapse) cherish a piece of clothing
    Mr Susumu Inarida, Emeritus Professor of Bunka Fashion Graduate University (BFGU) / Specially Appointed Committee Member of Japan Modelist Associate / Contemporary Master Craftsman Certified by the Ministry of Health, Labor and Welfare
  • "Mottainai!" sustainable initiatives from Osaka!
    Common points between Senshu Towl and OSAKA KABAN and the future
    Mr Eiji Shinoda, President of Shinoda cCorp
    Mr Kenji Fukuroya, Representative Employee of Fukuroya Joint Company etc.
  • About the sustainable fashion community “NewMake”- Upcycling initiatives in collaboration with brands
    Mr Tac Hosokawa, CEO of Story & Co.
  • Win - win strategy on underwear sewing, viewpoint of BISEI SANGYO Co., LTD
    Mr Toru Miyawaki, Managing Executive Officer of BISEI SANGYO Co.,LTD / Chairman of Hikoneseni Cooperative

Home Sewing Machine Zone
Catering to the B2C market, the Home Sewing Machine Zone, will feature major domestic household sewing machine suppliers. To promote the joy of sewing, a special workshop will be organised by Brother Industries Ltd, Janome Corp, JUKI Corp and JASMA covering topics such as the use of upcycled materials. As part of JIAM 2022 OSAKA’s sustainable development goals, visitors will be taught to sew “cup sleeves” using discarded items and materials from the DIY brand WHTATNOT. Attendees will also learn about upcycling, the process of upgrading unwanted items into new products that are useful. Another highlight will be the awards for JASMA’s “42th Home Sewing Competition for Elementary, Middle, and High School Students”.

Source:

JIAM, Messe Frankfurt Japan Ltd / Messe Frankfurt (HK) Limited

07.11.2022

CIBUTEX begrüßt MEWA als ein neues Mitglied

Die MEWA Textil-Service AG & Co. Management OHG hat sich der Genossenschaft CIBUTEX als Mitglied angeschlossen. MEWA ein Vorreiter in Sachen Nachhaltigkeit in der Textilservice-Branche.

Verantwortung und Umwelt sind zwei der Mewa-Grundwerte, die sie mit der Mitgliedschaft bei CIBUTEX und dem Recycling ihrer B2B-Alttextilien weiter in die Tat umsetzen möchten. „Unser Ziel ist es, Alttextilien im Stoffkreislauf zu halten – ein geeignetes und skalierbares Recyclingverfahren zu identifizieren, was auch mit Blick auf den Energieaufwand sinnvoll ist, ist eine echte Herausforderung“, sagt Nicole Kiefer, Trendscout Future Textile bei Mewa.

„Wir freuen uns sehr, Mewa als ein neues Mitglied unserer Genossenschaft begrüßen zu dürfen“, sagt Ralf Hellmann, CIBUTEX-Ansprechpartner der D-A-CH-Region. „Gemeinsam mit MEWA werden wir uns mit der Erarbeitung zukunftsfähiger Recyclinglösungen für Berufsbekleidung beschäftigen.“

Die MEWA Textil-Service AG & Co. Management OHG hat sich der Genossenschaft CIBUTEX als Mitglied angeschlossen. MEWA ein Vorreiter in Sachen Nachhaltigkeit in der Textilservice-Branche.

Verantwortung und Umwelt sind zwei der Mewa-Grundwerte, die sie mit der Mitgliedschaft bei CIBUTEX und dem Recycling ihrer B2B-Alttextilien weiter in die Tat umsetzen möchten. „Unser Ziel ist es, Alttextilien im Stoffkreislauf zu halten – ein geeignetes und skalierbares Recyclingverfahren zu identifizieren, was auch mit Blick auf den Energieaufwand sinnvoll ist, ist eine echte Herausforderung“, sagt Nicole Kiefer, Trendscout Future Textile bei Mewa.

„Wir freuen uns sehr, Mewa als ein neues Mitglied unserer Genossenschaft begrüßen zu dürfen“, sagt Ralf Hellmann, CIBUTEX-Ansprechpartner der D-A-CH-Region. „Gemeinsam mit MEWA werden wir uns mit der Erarbeitung zukunftsfähiger Recyclinglösungen für Berufsbekleidung beschäftigen.“

Source:

Dibella GmbH / CIBUTEX

(c) Global Fashion Agenda
04.11.2022

Highlights of the Global Fashion Summit Singapore Edition

Hosted outside of Copenhagen for the first time in its 13-year history, on 3 November, Global Fashion Summit assembled over 250 stakeholders representing manufacturers, garment workers, retailers, brands, suppliers, NGOs, policy, and innovators in Singapore and online to spur industry action. The Summit was presented by Global Fashion Agenda (GFA), the non-profit organisation that is accelerating the transition to a net positive fashion industry.
 
The latest edition of the Summit was centred around the theme ‘Alliances for a New Era’, building on dialogues from the June edition in Copenhagen and gathering leaders from across the entire value chain to elevate diverse voices and foster alliances within the fashion industry and beyond, to drive sustainable impact.
 

Hosted outside of Copenhagen for the first time in its 13-year history, on 3 November, Global Fashion Summit assembled over 250 stakeholders representing manufacturers, garment workers, retailers, brands, suppliers, NGOs, policy, and innovators in Singapore and online to spur industry action. The Summit was presented by Global Fashion Agenda (GFA), the non-profit organisation that is accelerating the transition to a net positive fashion industry.
 
The latest edition of the Summit was centred around the theme ‘Alliances for a New Era’, building on dialogues from the June edition in Copenhagen and gathering leaders from across the entire value chain to elevate diverse voices and foster alliances within the fashion industry and beyond, to drive sustainable impact.
 
The Summit’s first international edition facilitated more conversations with manufacturer and supply chain voices to discuss crucial challenges and opportunities around working collaboratively with brands on equal terms. The programme featured bold panels, case studies, masterclasses and leadership roundtables reflecting on topics including ‘Data Scarcity: A Crisis of Measurement?’, ‘Disruption for Better Wage Systems’, ’Community and Circularity’, ‘Connecting the EU Textiles Strategy with the Value Chain’ and ‘Our Energy Transformation Moment’.
 
Attendees heard from over 50 speakers including H.E. Sandra Jensen Landi, Ambassador of Denmark to Singapore & Ambassador-Designate of Denmark to Brunei; H.E. Iwona Piórko, Ambassador of the European Union to Singapore; Anne-Laure Descours, Chief Sourcing Officer, PUMA; Baptiste Le Gal, Chief Revenue Officer APAC, Vestiaire Collective; Christian James Smith, Head of Sustainability Stakeholder Engagement, Zalando; Ninh Trinh, Director of Responsible Sourcing & Sustainability, Target; Roger Lee, CEO, TAL Apparel; Wilson Teo, President, Singapore Fashion Council; Edwin Keh, Chief Executive Officer, The Hong Kong Research Institute of Textiles and Apparel, Ashila Dandeniya, Founder, StandUp Lanka; and more.

Key takeaways and highlights from the event include:

  • Global Fashion Agenda announced a new alliance with BBC Storyworks Commercial Productions to launch a film series on BBC.com, which is currently in the early stages of development. The new series will present human-centric stories focusing on both social and environmental sustainability in the fashion industry. It will be released to a wide audience in 2023.
  • Federica Marchionni outlined the crucial need for accurate and robust data to substantiate sustainability claims and credentials but acknowledged that the focus on finding ‘perfect’ data cannot be allowed to stifle progress. Global Fashion Agenda will build upon Summit discussions to reflect on how the industry can accurately measure and communicate sustainability performance and illuminate the data credibility challenges.
  • The session ‘Establishing circular fashion systems in Cambodia & Vietnam’ outlined the first steps taken by the Global Circular Fashion Forum to establish circular fashion systems in Vietnam and Cambodia with regional stakeholders, government, brand and manufacturer representation.
  • Throughout the Summit, the Innovation Forum connected fashion companies with sustainable solution providers. Exhibitors included Better Work , Circular Fashion Partnership, Compreli, Kno Global, Planatones by Noyon Lanka, Redress Design Award and The ID Factory.
  • Through conversations such as ‘Disruption for Better Wage Systems’ and ‘Empowering the Worker Majority’, there was a resounding message for people to consider the real people in the value chain. Ensuring dignified livelihoods for these workers should have the same sense of urgency as emissions reductions. 
Source:

Global Fashion Agenda

04.11.2022

Rieter publishes Investor Update 2022

  • Sales of CHF 366.8 million in the third quarter, CHF 987.4 million after nine months
  • Order intake of CHF 226.4 million in the third quarter, CHF 1 095.8 million after nine months
  • Order backlog of around CHF 2 000 million as of September 30, 2022
  • Precautionary measures taken against potential energy crisis in Europe
  • Financing of a Professorship for Artificial Intelligence
  • Rieter site sales process on schedule
  • Outlook 2022

Rieter recorded a significant increase in sales in the third quarter of 2022, reaching a level of CHF 366.8 million (2021: CHF 257.3 million). The measures introduced to increase sales and profitability in the second half of 2022 are taking effect and will continue to be implemented in a systematic manner. These include a close cooperation with key suppliers, the development of alternative solutions to eliminate material shortages, the enforcement of price increases, and the improvement of the margin quality of the order backlog.

  • Sales of CHF 366.8 million in the third quarter, CHF 987.4 million after nine months
  • Order intake of CHF 226.4 million in the third quarter, CHF 1 095.8 million after nine months
  • Order backlog of around CHF 2 000 million as of September 30, 2022
  • Precautionary measures taken against potential energy crisis in Europe
  • Financing of a Professorship for Artificial Intelligence
  • Rieter site sales process on schedule
  • Outlook 2022

Rieter recorded a significant increase in sales in the third quarter of 2022, reaching a level of CHF 366.8 million (2021: CHF 257.3 million). The measures introduced to increase sales and profitability in the second half of 2022 are taking effect and will continue to be implemented in a systematic manner. These include a close cooperation with key suppliers, the development of alternative solutions to eliminate material shortages, the enforcement of price increases, and the improvement of the margin quality of the order backlog.

The order intake of CHF 226.4 million in the third quarter of 2022 reflects the expected normalization of demand for new equipment compared to the record year of 2021, which was characterized by catch-up effects and the regional shift in demand. In addition, the well-known uncertainties and risks and the continuing extremely long delivery times at key manufacturers had a dampening effect on demand. Due to the slowdown in capacity utilization in the spinning mills, demand for consumables, wear & tear and spare parts also declined in the third quarter of 2022. Major orders continued to be recorded from Turkey, Uzbekistan, and China.

Rieter has a high order backlog of around CHF 2 000 million as of September 30, 2022 (September 30, 2021: CHF 1 562 million), which will guarantee capacity utilization in all three business groups until well into 2023 or rather 2024. The cancellation rate in the reporting period was around 5% of the order backlog.

Outlook 2022
Rieter anticipates weakened demand for new systems in the coming months. The demand for consumables, wear & tear and spare parts will depend on the capacity utilization of spinning mills in the months ahead.

For the full year 2022, Rieter expects sales of around CHF 1 400 million. The realization of sales revenue from the order backlog continues to be associated with risks in relation to the well-known uncertainties.

Despite significantly higher sales compared to the prior-year period, Rieter expects EBIT and net result for 2022 to be below the previous year’s level. This is due to the considerable increases in the cost of materials and logistics, additional costs for compensation of material shortages as well as expenses in connection with the acquisition in the years 2021/2022.

More information:
Rieter financial year 2022
Source:

Rieter Management AG

04.11.2022

Lectra published financial report for the first nine months of 2022

  • Revenues: 392.1 million euros (+50%)
  • EBITDA before non-recurring items: 74.9 million euros (+73%)
  • Net income: 35.4 million euros (multiplied by 2.1)
  • Free cash flow before non-recurring items: 31.6 million euros

Lectra’s Board of Directors, chaired by Daniel Harari, reviewed the consolidated financial statements for the third quarter and first nine months of 2022, which have not been reviewed by the Statutory Auditors.
To facilitate the analysis of the Group’s results, the financial statements are compared to those published in 2021 and to the 2021 pro forma financial statement ("2021 Pro forma"), prepared by integrating the three acquisitions made in 2021 – Gerber Technology (“Gerber”), Neteven, and Gemini CAD Systems (“Gemini”) – as if they had been consolidated from January 1, 2021, whereas they have been consolidated since June 1, July 28 and September 27, 2021 respectively.

See attached document for full report.

  • Revenues: 392.1 million euros (+50%)
  • EBITDA before non-recurring items: 74.9 million euros (+73%)
  • Net income: 35.4 million euros (multiplied by 2.1)
  • Free cash flow before non-recurring items: 31.6 million euros

Lectra’s Board of Directors, chaired by Daniel Harari, reviewed the consolidated financial statements for the third quarter and first nine months of 2022, which have not been reviewed by the Statutory Auditors.
To facilitate the analysis of the Group’s results, the financial statements are compared to those published in 2021 and to the 2021 pro forma financial statement ("2021 Pro forma"), prepared by integrating the three acquisitions made in 2021 – Gerber Technology (“Gerber”), Neteven, and Gemini CAD Systems (“Gemini”) – as if they had been consolidated from January 1, 2021, whereas they have been consolidated since June 1, July 28 and September 27, 2021 respectively.

See attached document for full report.

Source:

Lectra

(c) BVMed
03.11.2022

BVMed veröffentlicht Handreichungen zum Lieferketten-Sorgfaltspflichtengesetz

Der Bundesverband Medizintechnologie (BVMed) unterstützt die Medizintechnik-Branche bei der praktischen Umsetzung der neuen Pflichten aus dem Lieferketten-Sorgfaltspflichtengesetz (LkSG) mit einer kostenlosen Handreichung. Sie besteht aus insgesamt sechs Modulen, von denen die ersten drei Module bereits heruntergeladen werden können.

„Unser Ziel ist es, mit den Publikationen zu einem einheitlichen Branchenstandard für die Implementierung des LkSG in Medizinprodukte-Unternehmen beitragen. Damit erreichen wir Harmonisierung, Rechtssicherheit und Effizienz – und nicht zuletzt einen noch bewussteren Schutz der Menschenrechte und der Umwelt“, kommentiert BVMed-Geschäftsführer und Vorstandsmitglied Dr. Marc-Pierre Möll.

Die Module wurden vom BVMed gemeinsam mit der Kanzlei Clifford Chance und der Produktkanzlei entwickelt. Zusätzlich bietet der BVMed entsprechende LkSG-Schulungen an: Am 22. November 2022 exklusiv für seine Mitglieder sowie am 9. Dezember 2022 auch für Nicht-Mitglieder über die BVMed-Akademie.

Die kostenlose BVMed-Handreichung für Medizintechnik-Unternehmen besteht aus den folgenden sechs Modulen:

Der Bundesverband Medizintechnologie (BVMed) unterstützt die Medizintechnik-Branche bei der praktischen Umsetzung der neuen Pflichten aus dem Lieferketten-Sorgfaltspflichtengesetz (LkSG) mit einer kostenlosen Handreichung. Sie besteht aus insgesamt sechs Modulen, von denen die ersten drei Module bereits heruntergeladen werden können.

„Unser Ziel ist es, mit den Publikationen zu einem einheitlichen Branchenstandard für die Implementierung des LkSG in Medizinprodukte-Unternehmen beitragen. Damit erreichen wir Harmonisierung, Rechtssicherheit und Effizienz – und nicht zuletzt einen noch bewussteren Schutz der Menschenrechte und der Umwelt“, kommentiert BVMed-Geschäftsführer und Vorstandsmitglied Dr. Marc-Pierre Möll.

Die Module wurden vom BVMed gemeinsam mit der Kanzlei Clifford Chance und der Produktkanzlei entwickelt. Zusätzlich bietet der BVMed entsprechende LkSG-Schulungen an: Am 22. November 2022 exklusiv für seine Mitglieder sowie am 9. Dezember 2022 auch für Nicht-Mitglieder über die BVMed-Akademie.

Die kostenlose BVMed-Handreichung für Medizintechnik-Unternehmen besteht aus den folgenden sechs Modulen:

  • Modul 0: Anwendungsbereich
  • Modul 1: (Compliance-)Dokumentation
  • Modul 2: Ausgestaltung der Governance
  • Modul 3: Ausgestaltung des Beschwerdemechanismus
  • Modul 4: Risikoanalyse, -priorisierung, -prävention und -abhilfe
  • Modul 5: Jährliche Berichterstattung
Source:

BVMed | Bundesverband Medizintechnologie e.V.

03.11.2022

SGL Carbon: Positive business development in all business units

  • Positive business development in all four business units
  • Sales increases by 14.8% to €853.9 million
  • Adjusted EBITDA improves by 25.4% to €136.1 million
  • Successful refinancing of the 2018 convertible bonds

After €270.9 million in Q1 2022 and €278.9 million in Q2, SGL Carbon increased its consolidated sales to €304.1 million in Q3 2022. After nine months, this corresponds to a significant sales growth of 14.8% to a total of €853.9 million (9M 2021: €743.5 million). The positive business development is also reflected in the company's adjusted EBITDA, which improved by 25.4% year-on-year to €136.1 million (9M 2021: €108.5 million). All four business units contributed to the operating success.

Outlook
Due to the positive business development, the management increased the forecast for the full year on 6 September 2022. For the financial year 2022, Group sales of approx. €1.2 billion (previously: approx. €1.1 billion) and adjusted EBITDA of €170 to 190 million (previously: €130 to 150 million) are expected.

  • Positive business development in all four business units
  • Sales increases by 14.8% to €853.9 million
  • Adjusted EBITDA improves by 25.4% to €136.1 million
  • Successful refinancing of the 2018 convertible bonds

After €270.9 million in Q1 2022 and €278.9 million in Q2, SGL Carbon increased its consolidated sales to €304.1 million in Q3 2022. After nine months, this corresponds to a significant sales growth of 14.8% to a total of €853.9 million (9M 2021: €743.5 million). The positive business development is also reflected in the company's adjusted EBITDA, which improved by 25.4% year-on-year to €136.1 million (9M 2021: €108.5 million). All four business units contributed to the operating success.

Outlook
Due to the positive business development, the management increased the forecast for the full year on 6 September 2022. For the financial year 2022, Group sales of approx. €1.2 billion (previously: approx. €1.1 billion) and adjusted EBITDA of €170 to 190 million (previously: €130 to 150 million) are expected.

Consequently, an adjusted EBIT of €110 to 130 million (previously: €70 to 90 million) is forecasted. The expectations for return on capital employed (ROCE) of originally 7% to 9% are raised to 10% to 12% in line with the development of earnings. The estimate for free cash flow (significantly below the previous year's level of €111.5 million) remains unchanged.

Source:

SGL CARBON SE

02.11.2022

Nico Reiner as new Chief Financial Officer of Lenzing AG

The Supervisory Board of Lenzing AG, a world-leading provider of sustainably produced specialty fibers for the textile and nonwoven industries, has appointed Nico Reiner as its new Chief Financial Officer. Mr. Reiner will join Lenzing’s Managing Board led by Chief Executive Officer Stephan Sielaff on January 1, 2023. He will succeed Chief Financial Officer Thomas Obendrauf, who is leaving the company of his own volition after seven years.

Nico Reiner has held several positions in his professional career to date, including CFO at globally operating companies such as Schüco Group, AL-KO Group and Pfleiderer Group, as well as management consultant roles. His most recent appointment was as CFO of Vacuumschmelze GmbH & Co. KG, a global player with headquarters in Hanau that specializes in the development, production and marketing of magnetic materials.

The Supervisory Board of Lenzing AG, a world-leading provider of sustainably produced specialty fibers for the textile and nonwoven industries, has appointed Nico Reiner as its new Chief Financial Officer. Mr. Reiner will join Lenzing’s Managing Board led by Chief Executive Officer Stephan Sielaff on January 1, 2023. He will succeed Chief Financial Officer Thomas Obendrauf, who is leaving the company of his own volition after seven years.

Nico Reiner has held several positions in his professional career to date, including CFO at globally operating companies such as Schüco Group, AL-KO Group and Pfleiderer Group, as well as management consultant roles. His most recent appointment was as CFO of Vacuumschmelze GmbH & Co. KG, a global player with headquarters in Hanau that specializes in the development, production and marketing of magnetic materials.

Source:

Lenzing AG

01.11.2022

GOTS raises requirements for certified gins

To further advance the system, the Global Organic Textile Standard (GOTS) is significantly raising the requirements for GOTS-certified gins, to ensure transparent and traceable processing for organic textiles from field to finished product:

To further advance the system, the Global Organic Textile Standard (GOTS) is significantly raising the requirements for GOTS-certified gins, to ensure transparent and traceable processing for organic textiles from field to finished product:

  1. GOTS is introducing a compulsory farm-gin registry for all farms and farm groups whose certified raw material enters the GOTS system, including information on farm yields. The registry will be implemented progressively, starting in India.
  2. Raw cotton is not allowed to travel more than 500 km from the farm to the certified gin. The shorter trade chain protects vulnerable points and optimises the process for buyers.  
  3. Increase of unannounced audits of gins where there is a high perception of risk.

These new requirements are added to the numerous checks and balances which are already performed throughout every processing stage. Seed cotton entering the GOTS supply chain is tested for the presence of genetically modified organisms according to the applicable ISO protocol. GOTS-approved Certification Bodies (CBs) include further testing (such as pesticide residue) and are fully authorised to reject material that does not meet GOTS requirements. Additionally, before certification bodies issue a Transaction Certificate (TC), GOTS requires that a thorough assessment takes place, including a plausibility check in the form of volume reconciliation.

To strengthen integrity and traceability, GOTS also stipulates that the Farm TC number appears on the first GOTS TC at the ginning plant, which is the first step for cotton in the GOTS supply chain. The TC must state the origin for raw material, including region, state, and province. This effectively traces material back to the field and adds another layer of accountability to GOTS-certified fibre. It also supports all buyers in their purchasing decisions.

GOTS is not only improving its own system but also coordinating efforts with other key players to support the integrity of organic textiles. As GOTS provides certification of first processing stages to Textile Exchange's Organic Content Standard (OCS), GOTS and TE discussed new requirements for OCS while they were being developed. GOTS supports these requirements as they provide a dual protection shield for materials entering the GOTS or OCS supply chains, at the same time maintaining necessary data privacy. The new requirements will help increase traceability and transparency throughout the organic textile sector which are among the main objectives of GOTS. There are no changes necessary to the requirements of GOTS regarding any of the new OCS rules.

Source:

The Global Organic Textile Standard (GOTS)

31.10.2022

Cinte Techtextil China announces exhibitors for December Edition

From 7 – 9 December 2022, Cinte Techtextil China will welcome visitors sourcing solutions for 12 application areas of technical textiles and nonwovens at the National Exhibition and Convention Center in Shanghai.

A number of countries and regions are represented at the fair’s International Zone, with companies from Austria, Belgium, France, Germany, Hong Kong, Italy, the Netherlands, Spain, Sweden, Switzerland, Taiwan, and the US. Standout international exhibitors include:

From 7 – 9 December 2022, Cinte Techtextil China will welcome visitors sourcing solutions for 12 application areas of technical textiles and nonwovens at the National Exhibition and Convention Center in Shanghai.

A number of countries and regions are represented at the fair’s International Zone, with companies from Austria, Belgium, France, Germany, Hong Kong, Italy, the Netherlands, Spain, Sweden, Switzerland, Taiwan, and the US. Standout international exhibitors include:

  • TESTEX, an international, independent Swiss institute which specialises in the testing and certification of textile and leather products. The organisation is a founding member and official representative of the OEKO-TEX® Association, and will present their certification services at the fairground.
  • Cotton Council International (CCI) is a non-profit trade association that promotes US cotton fibre and manufactured cotton products, with their COTTON USA™ Mark. At this year’s fair they will showcase cotton spunlace fabric, wipes, kitchen tissues, facial masks, cosmetic removers, and more, with their products particularly applicable to Agrotech, Clothtech, Medtech, and Sporttech.
  • Graf + Cie AG is a subsidiary of the Rieter Group, and a leading supplier of clothing for carding and combs for combing machines in the short- and long-staple spinning industry. This year, the Swiss company will showcase stationary flats, and metallic card clothing for roller cards.
  • At the returning German Pavilion, buyers can source sought-after technical textiles and nonwovens that are renowned for their quality. The companies and expertise on display at this pavilion are endorsed by the Federal Republic of Germany, with several exhibitors highlighted below:
  • Brückner Textile Technologies GmbH & Co KG has developed machinery for the textile industry since 1949. Today, the company offers complete line systems for the dry finishing of both woven and knitted fabric, as well as for technical textiles, glass fibres, and floor coverings.
  • Perlon (Zhejiang) Co Ltd is part of a global group of companies that specialises in the manufacture of synthetic filaments, with factories in China, Germany, Poland, and the US. Their products have a diverse range of potential uses, largely categorised in the Agrotech and Indutech application areas.
  • IBENA Textilwerke GmbH produces various functional fabrics for Protech. At the fair, the company will be showcasing insulative, flame retardant (FR) textiles for firefighting and search & rescue services. Developed with DuPont™ aramid material, their FR properties will not diminish after washing or repeated use.

This year’s fair also sees the return of the Taiwan Zone. With support from the Taiwan Nonwoven Fabrics Industry Association, the area will showcase a range of industry leading nonwoven products and services, by brands such as KNH Enterprise, Nan Liu Enterprise, Unique Pretty Ind, and Web-Pro Corporation.

As a world’s largest manufacturer of technical textiles, China is home to a vast array of companies responsible for innovative products. Some domestic exhibitors to look out for are:

  • CTA Hi-Textiles Co Ltd, a high-tech enterprise controlled by China Textile Science Research Institute. In recent years, the company has developed several new textile composite materials, and their products are widely used in sectors such as national defence, policing and public security, medical protection, and engineering and manufacturing.
  • Sateri is one of the world’s largest producers of viscose fibre, with an annual capacity of 1.8 million metric tonnes. At their mills, they make yarn and fibre products applicable to sectors such as beauty, hygiene and personal care, medical, wipes, and protective wear.

To help international buyers stay connected with the Chinese market, Match Plus, the fair’s online business matching platform, will support foreign buyers achieve their sourcing goals despite travel limitations. Further information on Match Plus will be available at a later stage.

The fair’s product categories cover 12 application areas, which comprehensively span a full range of potential uses in modern technical textiles and nonwovens. These categories also cover the entire industry, from upstream technology and raw materials providers to finished fabrics, chemicals and other solutions.

31.10.2022

DC International has selected Fresh Relevance for personalized online experiences

Fresh Relevance announces that DC International has selected its versatile personalization platform to power personalized online experiences for its Coverstore and Leatherology brands.

DC International is a vertically integrated eCommerce company and home to two fast-growing direct-to-consumer brands: Coverstore and Leatherology. By selecting Fresh Relevance to power personalization across the website and email marketing of Coverstore and Leatherology, DC International will be providing shoppers with a more engaging and tailored online experience. The business will take advantage of the rich feature set within the Fresh Relevance platform, including product recommendations.

“We’re delighted to welcome DC International to the Fresh Relevance family and are excited to help them provide their Coverstore and Leatherology customers with a more tailored and valuable experience online,” says Mike Austin, CEO & Co-founder at Fresh Relevance.

Fresh Relevance announces that DC International has selected its versatile personalization platform to power personalized online experiences for its Coverstore and Leatherology brands.

DC International is a vertically integrated eCommerce company and home to two fast-growing direct-to-consumer brands: Coverstore and Leatherology. By selecting Fresh Relevance to power personalization across the website and email marketing of Coverstore and Leatherology, DC International will be providing shoppers with a more engaging and tailored online experience. The business will take advantage of the rich feature set within the Fresh Relevance platform, including product recommendations.

“We’re delighted to welcome DC International to the Fresh Relevance family and are excited to help them provide their Coverstore and Leatherology customers with a more tailored and valuable experience online,” says Mike Austin, CEO & Co-founder at Fresh Relevance.

Source:

Fresh Relevance / CHIEF PR

(c) EFI
31.10.2022

EFI sells 300th VUTEk FabriVU Printer

Orbus Exhibit & Display Group® has continued its substantial and longstanding relationship with digital print technology provider Electronics For Imaging, Inc., choosing the premium-quality capabilities of the EFI™ VUTEk® FabriVU® 340+ soft signage printer to meet surging demand for dye-sublimation soft signage graphics. The new printer now running at Orbus’s Las Vegas facility marks an important milestone for EFI, as it is the 300th EFI VUTEk FabriVU printer installed worldwide.

Orbus is North America’s top trade manufacturer of soft signage and flag graphics for tradeshow exhibits, promotional displays, experiential retail and corporate interiors. The company is one of the largest users of EFI soft signage printers worldwide. The newly installed FabriVU 340+ model joins two additional FabriVU printers at Orbus Las Vegas. The company has its fourth FabriVU printer at its headquarters facility, along with a pair of high-volume EFI industrial printers used exclusively for dye-sublimation production.

Orbus Exhibit & Display Group® has continued its substantial and longstanding relationship with digital print technology provider Electronics For Imaging, Inc., choosing the premium-quality capabilities of the EFI™ VUTEk® FabriVU® 340+ soft signage printer to meet surging demand for dye-sublimation soft signage graphics. The new printer now running at Orbus’s Las Vegas facility marks an important milestone for EFI, as it is the 300th EFI VUTEk FabriVU printer installed worldwide.

Orbus is North America’s top trade manufacturer of soft signage and flag graphics for tradeshow exhibits, promotional displays, experiential retail and corporate interiors. The company is one of the largest users of EFI soft signage printers worldwide. The newly installed FabriVU 340+ model joins two additional FabriVU printers at Orbus Las Vegas. The company has its fourth FabriVU printer at its headquarters facility, along with a pair of high-volume EFI industrial printers used exclusively for dye-sublimation production.

The upgraded performance comes courtesy of the VUTEk FabriVU 340+ printer’s new, eight-printhead, CMYK x 2 array, along with new electronics for reliable and consistent premium-quality output of exhibit graphics, backlit graphics, retail fixture wraps, front lit graphics, block-out banners and fabric interior decor. A flag printing kit on the printer easily handles porous media in high-penetration applications by collecting inks without touching the rear side of the media.
 
As with all VUTEk FabriVU printers, it prints both transfer paper and direct-to-fabric.

Source:

EFI

(c) Freudenberg Performance Materials Holding SE & Co. KG
31.10.2022

Freudenberg: Elastic superabsorbers for wound dressings

Freudenberg Performance Materials (Freudenberg) has launched an elastic variant of its flexible superabsorbers for modern wound dressings. These superabsorbers increase the comfort level for patients as well as enabling longer wear time, thus reducing the frequency of dressing changes. Freudenberg is debuting the elastic superabsorbers at this year’s Compamed in Düsseldorf, from November 14 – 17, 2022. Further highlights at the trade fair include components for more sustainable wound care, PU foams with directly applied silicone adhesives, and an innovative hydrophilic debridement foam.

Freudenberg uses a new technology to manufacture the elastic superabsorbers. Unlike other methods, this technology does not perforate or slit the material, thus achieving a high degree of consistent elasticity. Furthermore, the technology used by Freudenberg bonds the superabsorbent fibers more uniformly with the material, thus enhancing the integrity of this layer in the wound dressing.

Freudenberg Performance Materials (Freudenberg) has launched an elastic variant of its flexible superabsorbers for modern wound dressings. These superabsorbers increase the comfort level for patients as well as enabling longer wear time, thus reducing the frequency of dressing changes. Freudenberg is debuting the elastic superabsorbers at this year’s Compamed in Düsseldorf, from November 14 – 17, 2022. Further highlights at the trade fair include components for more sustainable wound care, PU foams with directly applied silicone adhesives, and an innovative hydrophilic debridement foam.

Freudenberg uses a new technology to manufacture the elastic superabsorbers. Unlike other methods, this technology does not perforate or slit the material, thus achieving a high degree of consistent elasticity. Furthermore, the technology used by Freudenberg bonds the superabsorbent fibers more uniformly with the material, thus enhancing the integrity of this layer in the wound dressing.

“Our new elastic superabsorbers demonstrate yet again how Freudenberg components help increase comfort for patients, reduce the workload for nursing staff and lower healthcare costs. Our extensive technology platform and our innovative strength are the basis for this,” Dr. Henk Randau, SVP and General Manager Global Division Healthcare at Freudenberg Performance Materials, said.

Source:

Freudenberg Performance Materials Holding SE & Co. KG

(c) C.L.A.S.S.
31.10.2022

C.L.A.S.S.: Launch of Imagining Sustainable Fashion Award 2023

The launch of the third edition of the Imagining Sustainable Fashion Award started on October 27, 2022. The Imagining Sustainable Fashion Award (ISFA) is the international competition born out of the collaboration between Connecting Cultures, the foundation that guides the Out of Fashion platform, and C.L.A.S.S., an international eco-hub that since 2007 has been advocating for a new generation of fashion in which the union of design, innovation, communication, and responsibility shapes a conscious and competitive business, capable of playing both an economic and social role.

The Imagining Sustainable Fashion Award invites stylists, photographers, designers, illustrators and artists to create visual imagery, a project that highlights awareness, respect for people and the planet that define the values of sustainable fashion in the fashion system.

Award submissions will be examined by an international jury composed of:

The launch of the third edition of the Imagining Sustainable Fashion Award started on October 27, 2022. The Imagining Sustainable Fashion Award (ISFA) is the international competition born out of the collaboration between Connecting Cultures, the foundation that guides the Out of Fashion platform, and C.L.A.S.S., an international eco-hub that since 2007 has been advocating for a new generation of fashion in which the union of design, innovation, communication, and responsibility shapes a conscious and competitive business, capable of playing both an economic and social role.

The Imagining Sustainable Fashion Award invites stylists, photographers, designers, illustrators and artists to create visual imagery, a project that highlights awareness, respect for people and the planet that define the values of sustainable fashion in the fashion system.

Award submissions will be examined by an international jury composed of:

  • Anna Detheridge, Founder and President, Connecting Cultures
  • Giusy Bettoni, CEO and Founder, C.L.A.S.S.
  • Rita Airaghi, Steering Advisor, Gianfranco Ferré Research Center
  • Paola Arosio, Head of New Brands & Sustainability Projects, Camera Nazionale della Moda Italiana
  • Jeanine Ballone Managing Director, Fashion 4 Development
  • Evie Evangelou, Founder and President, Fashion 4 Development
  • Sara Kozlowski, Vice President of Program Strategies, Education, and Sustainability Initiatives, Council of Fashion Designers of America
  • Dio Kurazawa, Founding Partner, The Bear Scouts
  • Renata Molho, journalist, former editor-in-chief of L'Uomo Vogue and former editor-at-large of L'Uomo Vogue, Vogue Italia, Casa Vogue
  • Stefania Ricci, Director, Museo Salvatore Ferragamo
  • Jovana Vukoje, Senior New Brands Specialist, Camera Nazionale della Moda Italiana

The winning projects of past editions were Take a Walk on the Green Side by Emma Scalcon (2021 - Italy) and Fashion Affair by Vishal Tolambia (2022 - India), two very different works that highlighted how challenging sustainability issues are in the contemporary communication landscape.

The deadline for submissions is Wednesday, January 25, 2023.
The winner will be announced in March 2023 and will receive a cash prize of €3,000.00.

(c) adidas AG
31.10.2022

and wander and adidas terrex present their outdoor collection

Inspired by this innate desire to experience nature and a shared vision, adidas TERREX has teamed up with fashion-forward Japanese outdoor label and wander on a collection that will take hikers from city centre to mountain top (and back again) in style.

Since its inception, adidas TERREX has focused on providing people with the clothing and apparel they need to realize their individual goals in the outdoors and enjoy the benefits of nature.

Tokyo designers Keita Ikeuchi and Mihoko Mori, meanwhile, launched their own outdoor label and wander in 2011 to bring more creativity to outdoors wear. By pairing high-fashion design with the practical requirements needed for adventure, theirs is a modern approach to apparel that works both in the wild, and on the streets.  

Together, adidas TERREX and and wander have collaborated on a multi-seasonal collection that ties these philosophies together to help people enjoy more outdoors experiences.

Inspired by this innate desire to experience nature and a shared vision, adidas TERREX has teamed up with fashion-forward Japanese outdoor label and wander on a collection that will take hikers from city centre to mountain top (and back again) in style.

Since its inception, adidas TERREX has focused on providing people with the clothing and apparel they need to realize their individual goals in the outdoors and enjoy the benefits of nature.

Tokyo designers Keita Ikeuchi and Mihoko Mori, meanwhile, launched their own outdoor label and wander in 2011 to bring more creativity to outdoors wear. By pairing high-fashion design with the practical requirements needed for adventure, theirs is a modern approach to apparel that works both in the wild, and on the streets.  

Together, adidas TERREX and and wander have collaborated on a multi-seasonal collection that ties these philosophies together to help people enjoy more outdoors experiences.

With a striking visual update, the lightweight TERREX Free Hiker 2 offers grip on a range of surfaces, and a responsive BOOST midsole that delivers incredible energy return. With a breathable upper and a sock-like fit that adapts to every step, this supportive shoe made in part with Parley Ocean Plastic is ready for adventure, anywhere.

With the TERREX Free Hiker 2 taking care of the feet, the TERREX XPLORIC and wander COLD.RDY Down Jacket is a functional essential with eye-catching design. COLD.RDY insulating material help keep the warmth in, while prominent TERREX x and wander reflective prints on the jacket and detachable hood help it stand out. With an array of pockets and adjustable features for the right fit, this versatile jacket’s natural habitat is everywhere. It’s also made in part with recycled materials.

adidas TERREX x and wander graphics and reflective detailing have been worked into the rest of an adventure-ready outdoor clothing collection that also includes a TERREX Fleece Jacket, loose-fit unisex TERREX Graphics Hoody and TERREX Pants.

Also available in the adidas TERREX x and wander collection are breathable Merino Wool Hiking Socks made with COLD.RDY technology for snug hiking , a quilted Winterized Bucket Hat, and a lightweight AERO.RDY Hiking Backpack that is loaded with features to look after outdoor essentials.

More information:
adidas Outdoor Clothing industry
Source:

adidas AG

31.10.2022

BVMed: Medizintechnik-Branche fordert legislative Maßnahmen

Neue Zahlen der Europäische Kommission zur Implementierung der EU-Medizinprodukte-Verordnung (MDR) zeigen nach Ansicht des Bundesverbandes Medizintechnologie (BVMed) zwar Tendenzen in die richtige Richtung, „nach mehr als fünf Jahren der Umsetzung verfügt das MDR-Regulierungssystem aber immer noch nicht über ausreichende Zertifizierungskapazitäten“, so BVMed-Geschäftsführer und Vorstandsmitglied Dr. Marc-Pierre Möll. Die europäische Medizintechnik-Branche fordert daher in einem Schreiben an die EU-Kommission und Gesundheitsminister:innen der EU-Mitgliedsstaaten, zusätzlich zu den bisher durchgeführten untergesetzlichen Lösungen, „legislative Maßnahmen“ auf dem EPSCO-Meeting im Dezember 2022 zu beschließen. Dazu gehören die Verlängerung der Übergangsfristen nach einem risikobasierten Ansatz oder die Abschaffung der bestehenden Abverkaufsfrist.

Die EU-Kommission hat Ende Oktober 2022 unter anderem folgende aktuelle Zahlen zur MDR vorgestellt:

Neue Zahlen der Europäische Kommission zur Implementierung der EU-Medizinprodukte-Verordnung (MDR) zeigen nach Ansicht des Bundesverbandes Medizintechnologie (BVMed) zwar Tendenzen in die richtige Richtung, „nach mehr als fünf Jahren der Umsetzung verfügt das MDR-Regulierungssystem aber immer noch nicht über ausreichende Zertifizierungskapazitäten“, so BVMed-Geschäftsführer und Vorstandsmitglied Dr. Marc-Pierre Möll. Die europäische Medizintechnik-Branche fordert daher in einem Schreiben an die EU-Kommission und Gesundheitsminister:innen der EU-Mitgliedsstaaten, zusätzlich zu den bisher durchgeführten untergesetzlichen Lösungen, „legislative Maßnahmen“ auf dem EPSCO-Meeting im Dezember 2022 zu beschließen. Dazu gehören die Verlängerung der Übergangsfristen nach einem risikobasierten Ansatz oder die Abschaffung der bestehenden Abverkaufsfrist.

Die EU-Kommission hat Ende Oktober 2022 unter anderem folgende aktuelle Zahlen zur MDR vorgestellt:

  • Von 80 unter den alten Richtlinien designierten Benannten Stellen haben 62 Stellen MDR-Anträge gestellt.
  • Mittlerweile gibt es 34 Benannte Stellen unter der MDR.
  • Rund 23.000 Zertifikate müssen noch in die MDR überführt werden.
  • Über 75 Prozent (17.000) dieser Zertifikate laufen im Mai 2024 aus.
  • Bislang – Stand: Oktober 2022 – wurden 8.120 Anträge angenommen und 1.990 MDR-Zertifikate ausgestellt. Im April 2022 waren es 1.069 Zertifikate.
  • Die Bearbeitungszeit liegt bei keinem einzigen MDR-Zertifikat (QMS und Produktprüfung) unter einem Jahr. 82 Prozent der Zertifikate dauern zwischen 13 und 18 Monaten, 18 Prozent zwischen 19 und 24 Monaten.

„Die Zahlen zeigen, dass zwar seit April 2022 mehr Zertifikate ausgestellt wurden, die Kapazitäten aber weiterhin bei weitem nicht für die Gesamtheit der Zertifikate ausreichen werden, um negative Folgen für die Patient:innenversorgung und die Markteinführung von Innovationen zu verhindern“, so BVMed-Geschäftsführer Möll. In einem vom europäischen Dachverband MedTech Europe koordinierten Schreiben an die EU-Kommission und die Gesundheitsminister:innen der EU-Mitgliedsstaaten haben deshalb über 300 Verbände und Unternehmen der Medizintechnik-Branche kürzlich „dringenden Handlungsbedarf für den Gesetzgeber“ bei der Umsetzung der MDR angemahnt.

Der vom Bundesgesundheitsministerium (BMG) begonnene Dialogprozess und die Vorschläge der Medical Device Coordination Group (MDCG) auf EU-Ebene seien zwar gute Ansätze, aber es sind weitere Schritte notwendig. „Wenn nicht unverzüglich Maßnahmen ergriffen werden, steht Europa vor einem Szenario, in dem eine große Anzahl bestehender Medizinprodukte, auf die sich Patient:innen, Krankenhäuser und andere Gesundheitseinrichtungen verlassen, nicht rechtzeitig rezertifiziert werden und daher Gefahr laufen, dauerhaft vom Markt zu verschwinden“, heißt es in dem Schreiben. „Gleichzeitig verzögert sich die Zertifizierung neuer und verbesserter Produkte, was dazu führt, dass die Patient:innen erst mit Verzögerung von den Vorteilen der Innovation profitieren.“ Die anhaltende COVID-19-Pandemie und die Folgen des russischen Angriffskrieges gegen die Ukraine hätten diese Situation durch Unterbrechungen der Lieferketten, deutliche Erhöhung der Energiepreise und Probleme bei der Durchführung von Audits vor Ort sowie bei klinischen Prüfungen noch verschärft.

Zusätzlich zu untergesetzlichen Lösungen seien daher so bald wie möglich legislative Maßnahmen erforderlich, heißt es in dem Schreiben, das unter anderem an den deutschen Gesundheitsminister Prof. Dr. Karl Lauterbach ging. Die europäische Medizintechnik-Industrie fordert darin:

  1. Verlängerung der Gültigkeit der Richtlinienzertifikate (Richtlinie über Medizinprodukte und Richtlinie über aktive implantierbare medizinische Geräte), um Bestandsprodukte verkehrsfähig zu erhalten. Diese Verlängerungen sollten analog zur Änderung der Verordnung über In-vitro-Diagnostika im Januar 2022 anhand eines risikobasierten Ansatzes erfolgen, also mit unterschiedlichen Fristen je Risikoklasse der Produkte.
  2. Zertifikate unter Auflagen für Bestandsprodukte sowie wesentlich geänderten und neuen Produkten, um beispielsweise mehr Zeit für die Zusammenstellung weiterer Daten und Nachweise zu schaffen, die zur Erfüllung der MDR-Anforderungen erforderlich sind.
  3. Abschaffung der in Artikel 120 Absatz 4 der MDR festgelegten Abverkaufsfrist, um die Bereitstellung bereits in Verkehr gebrachter Medizinprodukte über das Enddatum Mai 2025 hinaus zu ermöglichen. Auf diese Weise lässt sich die unnötige Entsorgung oder der Rückruf von bereits in Verkehr gebrachten sicheren Medizinprodukte vermeiden.

„Wir müssen diese gesetzgeberischen Maßnahmen zügig umsetzen – und gleichzeitig daran arbeiten, die Rolle Europas als attraktive Region für Investitionen in medizintechnische Innovationen zu stärken“, so der Appell von BVMed-Geschäftsführer Dr. Marc-Pierre Möll.

Source:

BVMed | Bundesverband Medizintechnologie e.V.

31.10.2022

Autoneum: Long-term financing sustainably secured

Autoneum Holding Ltd signed a new loan agreement with a syndicate of banks led by UBS and Credit Suisse on the 31st of October 2022. This loan agreement replaces with immediate effect the existing syndicated loan, which was due to run until December 31, 2022.

The credit line specified under the new agreement remains at CHF 350 million and includes a substantial financial reserve for the Company. The main provisions of the previous loan agreement also apply unchanged to the new loan agreement, which runs for five years until October 31, 2027.

“We are pleased to have concluded this loan agreement, which secures the Group’s long-term financing,” said Bernhard Wiehl, Chief Financial Officer at Autoneum. “It is also important to say at this point that Autoneum has managed to further strengthen its financial stability over the last three years despite the corona crisis and a challenging environment in the automotive industry. Positive cash flow development over the past two years has enabled Autoneum to continuously reduce net debt since 2020.”

Autoneum Holding Ltd signed a new loan agreement with a syndicate of banks led by UBS and Credit Suisse on the 31st of October 2022. This loan agreement replaces with immediate effect the existing syndicated loan, which was due to run until December 31, 2022.

The credit line specified under the new agreement remains at CHF 350 million and includes a substantial financial reserve for the Company. The main provisions of the previous loan agreement also apply unchanged to the new loan agreement, which runs for five years until October 31, 2027.

“We are pleased to have concluded this loan agreement, which secures the Group’s long-term financing,” said Bernhard Wiehl, Chief Financial Officer at Autoneum. “It is also important to say at this point that Autoneum has managed to further strengthen its financial stability over the last three years despite the corona crisis and a challenging environment in the automotive industry. Positive cash flow development over the past two years has enabled Autoneum to continuously reduce net debt since 2020.”

With the syndicated loan, the Group’s liquidity and long-term financing continue to be sustainably secured through a broad-based syndicate of twelve banks.

Source:

Autoneum Management AG