From the Sector

Der Bundesverband Medizintechnologie (BVMed) fordert in seinem Positionspapier zur Europawahl am 9. Juni 2024 einen eigenen Gesundheitsausschuss im Europäischen Parlament, um den gestiegenen Stellenwert der Gesundheitsthemen abzubilden. Unter dem Titel „Medizintechnik-Standort Europa stärken“ ist es für den deutschen Medizintechnik-Verband besonders wichtig, dass Europa Lehren aus der Corona-Pandemie zieht, die Resilienz des Gesundheitssystems stärkt und damit die medizinische Versorgung krisenfest gestaltet. „Wir brauchen als MedTech-Branche vor allem einen einheitlichen regulatorischen Rahmen – ohne zusätzliche oder gar weitergehende Standards in den einzelnen Mitgliedsstaaten“, so BVMed-Geschäftsführer und Vorstandsmitglied Dr. Marc-Pierre Möll.

Um ein widerstandsfähiges Gesundheitssystem zu schaffen, fordert der BVMed attraktive Rahmenbedingungen für lokale Produktion und die Stärkung der Resilienz der Lieferketten. Eine „digitale Bestandsplattform für versorgungskritische Medizinprodukte und Arzneimittel“ könne zudem dazu beitragen, dass kritische Produkte uneingeschränkt zur Verfügung stehen. Sinnvoll sei auch eine „Whitelist für kritische Rohstoffe unter dem Critical Raw Materials Act“. Bei der Erarbeitung von politischen Maßnahmen zur Verbesserung der Effizienz und Integrität von Lieferketten müssen alle relevanten Stakeholder einbezogen werden – „inklusive der Medizintechnikbranche“, heißt es im BVMed-Europapapier.

Beim Thema Nachhaltigkeit spricht sich der MedTech-Verband dafür aus, die Vorgaben des europäischen Green Deals am Wohl der Patient:innen auszurichten. „Neue oder geänderte Regulierungen dürfen niemals die Versorgung von Patient:innen gefährden“, heißt es im Positionspapier. Da Produktänderungen zeit- und ressourcenintensiv sowie in der EU-Medizinprodukte-Verordnung (MDR) streng reguliert seien, benötigen umwelt- und nachhaltigkeitsbezogene Regulierungen, die Auswirkungen auf die Gesundheitsversorgung haben, angemessene Ausnahmeregelungen und Übergangsfristen.

Ein wichtiges Anliegen sind dem BVMed die Verbesserungen der MDR, um einen effizienten regulatorischen Rahmen für Medizinprodukte zu schaffen, der die Patient:innenversorgung gewährleistet. Der BVMed fordert daher unter anderem die Abschaffung der fünfjährigen Re-Zertifizierungs-Pflicht, die Einführung eines Fast-Track-Verfahrens für innovative Produkte, Orphan Devices und Nischenprodukte, die Steigerung der Effizienz, der Transparenz und der Berechenbarkeit des MDR-Systems sowie die Zusammenführung der Verantwortung im System über eine zu schaffende Governance-Struktur. Doppelregulierungen müssten durch die Harmonisierung der Anforderungen in verschiedenen Rechtsakten verhindert werden.

Ein weiterer Schwerpunkt der Positionen des deutschen MedTech-Verbandes ist es, Innovationen voranzutreiben und Digitalisierung zu forcieren. Der Europäische Raum für Gesundheitsdaten (EHDS) lege die Grundlage für den Datenaustausch und die Datennutzung für Unternehmen. Der Artificial Intelligence Act (AI-Act) solle bessere Möglichkeiten für die KI-Entwicklung schaffen, bringe aber auch neue Pflichten für Medizinprodukte mit sich, die effizient mit der bestehenden MDR in Einklang gebracht werden müssten. Der BVMed setzt sich für die Schaffung eines echten Binnenmarkts für digitale Gesundheitslösungen mit europaweiten Zulassungen und einheitlichen Standards für Datensicherheit aus. Der EHDS müsse allen Stakeholdern einen gleichberechtigten mit geringem bürokratischem Aufwand bieten. Außerdem müsste die Interoperabilität von Daten auf der Grundlage von international anerkannten Standards ausgebaut werden – „bei weitgehendem Verzicht auf nationale Besonderheiten bei Datenstandards“.

Schließlich sei es auf europäischer Ebene wichtig, Handel auszubauen, Fachkräfte zu sichern und Exporte zu stärken. Tendenzen der Renationalisierung und des Protektionismus erschwerten Europa die Handelsbeziehungen mit Drittstaaten und sorgen für erhebliche Marktzugangshürden. „Eine offene Handelspolitik ist jedoch für die exportstarke Medizintechnik-Branche ein entscheidender Faktor. Damit die Industrie so stark bleibt, bedarf es zudem der Sicherung des nötigen Fachkräftebedarfes“, heißt es in dem BVMed-Papier.

STFI will be presenting high-end textile products and solutions at Techtextil 2024. The highlights from current research results and innovations provide an insight into the digitalisation of textile production, show applications for 3D printing and smart technical textiles and provide examples of particularly sustainably designed products as well as innovative approaches for protective and medical textiles.

The central highlight of STFI's presence at Techtextil is a robot system that demonstrates the automated processing of a bobbin frame on a small scale. The pick-and-place application demonstrates camera-supported gripping of the bobbins. The robot is part of the STFI's “Textile Factory of the Future” which demonstrates automation solutions for the textile industry in a laboratory environment.

From the field of sustainable products and solutions, a sleeping bag with bio-based and therefore vegan filling material and a natural fibre-based composite element for furniture construction, in which LEDs and capacitive proximity sensors for contactless function control have been applied using embroidery technology, will be on show. Printed heating conductor structures demonstrate current research work for the e-mobility of the future, as the individually controllable seat and interior heating should ultimately reduce weight and save energy compared to conventional heating systems.

While a protective suit for special task forces protects against the dangers of a Molotov cocktail attack, a shin guard and a knee brace with patellar ring illustrate the process combination of 3D printing and UV LED cross-linking. Other highlights from lightweight textile construction include the rib of a vertical rudder of an Airbus A320 and a green snowboard made from recycled carbon fibres.

Textiles for technical applications often derive their special function via the application of coatings. This way, textiles become, for example wind and water proof or more resistant to abrasion. Usually, petroleum-based substances such as polyacrylates or polyurethanes are used. However, these consume exhaustible resources and the materials can end up in the environment if handled improperly. Therefore, the German Institutes of Textile and Fiber Research Denkendorf (DITF) are researching materials from renewable sources that are recyclable and do not pollute the environment after use. Polymers that can be produced from bacteria are here of particular interest.

These biopolymers have the advantage that they can be produced in anything from small laboratory reactors to large production plants. The most promising biopolymers include polysaccharides, polyamides from amino acids and polyesters such as polylactic acid or polyhydroxyalkanoates (PHAs), all of which are derived from renewable raw materials. PHAs is an umbrella term for a group of biotechnologically produced polyesters. The main difference between these polyesters is the number of carbon atoms in the repeat unit. To date, they have mainly been investigated for medical applications. As PHAs products are increasingly available on the market, coatings made from PHAs may also be increasingly used in technical applications in the future.

The bacteria from which the PHAs are obtained grow with the help of carbohydrates, fats and an increased CO₂ concentration and light with suitable wavelength.

The properties of PHA can be adapted by varying the structure of the repeat unit. This makes polyhydroxyalkanoates a particularly interesting class of compounds for technical textile coatings, which has hardly been investigated to date. Due to their water-repellent properties, which stem from their molecular structure, and their stable structure, polyhydroxyalkanoates have great potential for the production of water-repellent, mechanically resilient textiles, such as those in demand in the automotive sector and for outdoor clothing.

The DITF have already carried out successful research work in this area. Coatings on cotton yarns and fabrics made of cotton, polyamide and polyester showed smooth and quite good adhesion. The PHA types for the coating were both procured on the open market and produced by the research partner Fraunhofer IGB. It was shown that the molten polymer can be applied to cotton yarns by extrusion through a coating nozzle. The molten polymer was successfully coated onto fabric using a doctor blade. The length of the molecular side chain of the PHA plays an important role in the properties of the coated textile. Although PHAs with medium-length side chains are better suited to achieving low stiffness and a good textile handle, their wash resistance is low. PHAs with short side chains are suitable for achieving high wash and abrasion resistance, but the textile handle is somewhat stiffer.

The team is currently investigating how the properties of PHAs can be changed in order to achieve the desired resistance and textile properties in equal measure. There are also plans to formulate aqueous formulations for yarn and textile finishing. This will allow much thinner coatings to be applied to textiles than is possible with molten PHAs.

Other DITF research teams are investigating whether PHAs are also suitable for the production of fibers and nonwovens.

From Resource-efficient and Recycled Fibres for Textiles and Building Panels to Geotextiles for Glacier Protection: Six award nominees present innovative and sustainable solutions for various industries in the cellulose fibre value chain. The full economic potential of the cellulose fibre industry will be introduced to a wide audience that will vote for the winners in Cologne (Germany), and online.

Again nova-Institute grants the “Cellulose Fibre Innovation of the Year” award in the context of the “Cellulose Fibres Conference”, that will take place in Cologne on 13 and 14 March 2024. In advance, the conferences advisory board nominated six remarkable products, including cellulose fibres from textile waste and straw, a novel technology for dying cellulose-based textiles and a construction panel as well as geotextiles. The innovations will be presented by the companies on the first day of the event. All conference participants can vote for one of the six nominees and the top three winners will be honoured with the “Cellulose Fibre Innovation of the Year” award. The Innovation award is sponsored by GIG Karasek (AT).

In addition, the ever-growing sectors of cellulose-based nonwovens, packaging and hygiene products offer conference participants insights beyond the horizon of traditional textile applications. Sustainability and other topics such as fibre-to-fibre recycling and alternative fibre sources are the key topics of the Cellulose Fibres Conference, held in Cologne, Germany, on 13 and 14 March 2024 and online. The conference will showcase the most successful cellulose-based solutions currently on the market or those planned for the near future.

The nominees:

The Straw Flexi-Dress: Design Meets Sustainability – DITF & VRETENA (DE)
The Flexi-Dress design was inspired by the natural golden colour and silky touch of HighPerCell® (HPC) filaments based on unbleached straw pulp. These cellulose filaments are produced using environmentally friendly spinning technology in a closed-loop production process. The design decisions focused on the emotional connection and attachment to the HPC material to create a local and circular fashion product. The Flexi-Dress is designed as a versatile knitted garment – from work to street – that can be worn as a dress, but can also be split into two pieces – used separately as a top and a straight skirt. The top can also be worn with the V-neck front or back. The HPC textile knit structure was considered important for comfort and emotional properties.

HONEXT® Board FR-B (B-s1, d0) – Flame-retardant Board made From Upcycled Fibre Waste From the Paper Industry – Honext Material (ES)
HONEXT® FR-B board (B-s1, d0) is a flame-retardant board made from 100 % upcycled industrial waste fibres from the paper industry. Thanks to innovations in biotechnology, paper sludge is upcycled – the previously “worthless” residue from paper making – to create a fully recyclable material, all without the use of resins. This lightweight and easy-to-handle board boasts high mechanical performance and stability, along with low thermal conductivity, making it perfect for various applications in all interior environments where fire safety is a priority. The material is non-toxic, with no added VOCs, ensuring safety for both people and the planet. A sustainable and healthy material for the built environment, it achieves Cradle-to-Cradle Certified GOLD, and Material Health CertificateTM Gold Level version 4.0 with a carbon-negative footprint. Additionally, it is verified in the Product Environmental Footprint.

LENZING™ Cellulosic Fibres for Glacier Protection – Lenzing (AT)
Glaciers are now facing an unprecedented threat from global warming. Synthetic fibre-based geotextiles, while effective in slowing down glacier melt, create a new environmental challenge: microplastics contaminating glacial environments. The use of such materials contradicts the very purpose of glacier protection, as it exacerbates an already critical environmental problem. Recognizing this problem, the innovative use of cellulosic LENZING™ fibres presents a pioneering solution. The Institute of Ecology, at the University of Innsbruck, together with Lenzing and other partners made first trials in 2022 by covering small test fields with LENZING™ fibre-based geotextiles. The results were promising, confirming the effectiveness of this approach in slowing glacier melt without leaving behind microplastic.

The RENU Jacket – Advanced Recycling for Cellulosic Textiles – Pangaia (UK) & Evrnu (US)
PANGAIA LAB was born out of a dream to reduce barriers between people and the breakthrough innovations in material science. In 2023, PANGAIA LAB launched the RENU Jacket, a limited edition product made from 100% Nucycl® – a technology that recycles cellulosic textiles by breaking them down to their molecular building blocks, and reforming them into new fibres. This process produces a result that is 100% recycled and 100% recyclable when returned to the correct waste stream – maintaining the strength of the fibre so it doesn’t need to be blended with virgin material.
Through collaboration with Evrnu, the PANGAIA team created the world’s first 100% chemically recycled denim jacket, replacing a material traditionally made from 100% virgin cotton. By incorporating Nucycl® into this iconic fabric construction, dyed with natural indigo, the teams have demonstrated that it’s possible to replace ubiquitous materials with this innovation.

Textiles Made from Easy-to-dye Biocelsol – VTT Technical Research Centre of Finland (FI)
One third of the textile industry’s wastewater is generated in dyeing and one fifth in finishing. But the use of chemically modified Biocelsol fibres reduces waste water. The knitted fabric is made from viscose and Biocelsol fibres and is only dyed after knitting. This gives the Biocelsol fibres a darker shade, using the same amount of dye and no salt in dyeing process. In addition, an interesting visual effect can be achieved. Moreover, less dye is needed for the darker colour tone in the finished textile and the possibility to use the salt-free dyeing is more environmentally friendly.
These special properties of man-made cellulosic fibres will reassert the fibres as a replacement for the existing fossil-based fibres, thus filling the demand for more environmentally friendly dyeing-solutions in the textile industry. The functionalised Biocelsol fibres were made in Finnish Academy FinnCERES project and are produced by wet spinning technique from the cellulose dope containing low amounts of 3-allyloxy-2-hydroxypropyl substituents. The functionality formed is permanent and has been shown to significantly improve the dyeability of the fibres. In addition, the functionalisation of Biocelsol fibres reduces the cost of textile finishing and dyeing as well as the effluent load.

A New Generation of Bio-based and Resource-efficient Fibre – TreeToTextile (SE)
TreeToTextile has developed a unique, sustainable and resource efficient fibre that doesn't exist on the market today. It has a natural dry feel similar to cotton and a semi-dull sheen and high drape like viscose. It is based on cellulose and has the potential to complement or replace cotton, viscose and polyester as a single fibre or in blends, depending on the application.
TreeToTextile Technology™ has a low demand for chemicals, energy and water. According to a third party verified LCA, the TreeToTextile fibre has a climate impact of 0.6 kg CO2 eq/kilo fibre. The fibre is made from bio-based and traceable resources and is biodegradable.

Toray Industries, Inc. announced the successful development of recycled carbon fiber (rCF) derived from the production process of the Boeing 787 components using Toray’s advanced carbon fiber, TORAYCA™. The rCF, which is based on pyrolysis recycling process, has been integrated into the Lenovo ThinkPad X1 Carbon Gen 12 as reinforcement filler for thermoplastic pellets. Toray and Lenovo will continue to collaborate to expand the usage of rCF in other Lenovo products.

Toray rCF is the outcome of Boeing and Lenovo’s shared commitment to minimize their environmental impact. Boeing’s objective is to reduce solid waste going to landfill and produce recyclable materials, while Lenovo has been exploring materials to reduce the carbon footprint of their products. Toray rCF connects these visions by repurposing Toray’s high-performance carbon fiber from the Boeing aircraft production process into Lenovo’s ultra-light laptop PC.

TORAYCA™ is an established aerospace material known for its high strength, stiffness, and lightweighting properties. These qualities have led to its adoption in other applications such as electrical and electronic equipment housings, sports equipment, and other industrial applications.

A key advantage of carbon fiber is the ability to retain its primary mechanical properties even after the recycling process. Toray is actively advancing recycling technologies and establishing a strategic business model for rCF. Given that the carbon footprint of rCF is lower than that of virgin carbon fiber, Toray is proactively recommending the adoption of rCF to reduce the environmental impact of customers’ products. This commitment aligns with Toray’s dedication to fostering a circular economy, thereby reducing landfill waste.

Faster and more cost-effective carbon fibre production - the technology of the start-up CarboScreen comes a good deal closer to this dream. The founders Dr. Musa Akdere, Felix Pohlkemper and Tim Röding from the Institut für Textiltechnik (ITA) of RWTH Aachen University are using sensor technology to monitor carbon fibre production, thereby doubling the production speed from the current 15 to 30 m/min in the medium term and increasing turnover by up to €37.5 million per year and system. This ground-breaking development also impressed the jury at the ITMF at their Annual Conference in Keqiao, China, and was honoured with the ITMF StartUp Award 2023 on 6 November 2023.

Dr. Musa Akdere accepted the award on behalf of the CarboScreen founding team.

Carbon fibres can only develop their full potential if they are not damaged during production and further processing. Two types of fibre damage occur more frequently during fibre production: Superficial or mechanical damage to the fibres or damage to the chemical structure.

Both types of damage cannot be optimally detected by current means or only become apparent after production, to name just two examples. This leads to higher production costs. In an emergency, faulty production can even lead to plant fires. For this reason, and to ensure good production quality, the system is run at 15 m/min below its production capacity for safety reasons. However, 30 m/min or more would be possible. With the sensor-based online monitoring of CarboScreen, the production capacity can be doubled to 30 /min. This would lead to higher production, resulting in lower manufacturing costs and wider use of carbon fibres in mass markets such as automotive, aerospace and wind energy.

Cinte Techtextil China 2024, one of Asia’s leading technical textiles and nonwovens trade fair, will take place from 19 – 21 September 2024 at the Shanghai New International Expo Centre. In its capacity as a well-established platform for the latest textiles, nonwovens, and equipment, the 18th edition of the fair will offer business opportunities across the industry supply chain. With the previous edition attracting 467 exhibitors from 13 countries and regions across 40,000 sqm, the organisers are looking to build on that success at next year’s show.

With next year’s fair expected to again see strong domestic and international participation, the previous edition featured the return of the Taiwan Pavilion, the 40-exhibitor strong European Zone, and seven Chinese regional pavilions. At every edition, multiple fringe events enhance business connections and provide insights to fairgoers. In 2023, key highlights included the 11th China International Nonwovens Conference, the Advanced Technical Textiles Industry Chain Synergistic Innovation Development Forum, various marine textile and rope netting events, and the “Kingsafe Dangs” University Students’ Showcase.

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. This scope of product groups and application areas ensures that the fair is an effective business platform for the entire industry.

The fair is organised by Messe Frankfurt (HK) Ltd; the Sub-Council of Textile Industry, CCPIT; and the China Nonwovens & Industrial Textiles Association (CNITA).

On display at Sculpture by the Sea, the land art event that brings the Sydney coastline to life every year, is “Seabilia”, Elena Redaelli’s latest work created using waste fabric from Sitip’s production processes. A creation that draws attention to the environment and its fragility in the face of human activity, “Seabilia” is a reminder of how precious yet delicate this balance is, and how humans must become mindful of their actions before the effects end up being completely irreversible.

Sitip's commitment to environmental sustainability struck a chord with Elena Redaelli, and a meeting between the Bergamo-based textile company and the artist from Erba, Italy, led to “Seabilia”, a work that will be displayed as part of Sculpture by the Sea on Tamarama Beach near Bondi in Sydney.

It’s one of the most popular events to take place in this corner of Australia, attracting half a million visitors who flock to these Aussie beaches to admire more than one hundred works created by artists from all over the world.

Held since 1997, this event captures the imagination of its visitors for three weeks each austral spring and, thanks to the vast area it covers, has earned the title of largest annual sculpture exhibition in the world.

The 2023 edition, scheduled to take place from 20 October to 6 November, will feature Elena Redaelli's work created using waste Native-Cosmopolitan Kyoto fabric which, having failed the company's quality control tests, was donated to the artist.

A post-consumer recycled circular knit fabric composed of 89% recycled polyester (PLR), 11% elastane (EA), and weighing 240 grams, the Native-Cosmopolitan Kyoto is made from recycled yarns derived from plastic waste that’s been recovered from the environment, particularly from the sea and from recycling centres. The fabric is Bluesign, GRS (Global Recycled Standard) and OEKO-TEX certified, attesting to Sitip's commitment to environmental responsibility and protection.

During the process, the artist hand-cut the waste fabric and crocheted the pieces together using recycled cotton and other types of thread.

In the creative mind of the artist, the genesis of “Seabilia” arose from deep in the ocean where tiny creatures inhabit the darkest, least explored parts of the planet. A place where the rhythm of life for the inhabitants is marked by silence and obscurity, while waves and tides agitate the surface above. The life of the ocean, such a vast and imposing environment, is impacted every single day by human activity, slowly weakening its delicate balance. “Seabilia” is intended to act as a reminder of how precious yet extremely fragile this balance is, and how humans must become more aware of the consequences of their actions before it’s too late and such a vital asset is lost forever.

“Following Emersione, a work that was exhibited at the Ex Ateneo in Bergamo during Fiber Storming, a textile art exhibition organised by ArteMorbida Textile Arts Magazine and curated by Barbara Pavan, Seabilia is the second art project where I’ve had the opportunity to utilise SITIP's fabrics. – explains the artist, Elena Redaelli. As it was going to be displayed on the rocks at Tamarama Beach, my installation needed a durable, elastic fabric with structural characteristics capable of withstanding ocean winds and sudden changes in weather. Using waste Native-Cosmopolitan Kyoto fabric was the obvious choice, not just because of its very high quality, but also, and more importantly, because it’s made from recycled yarns derived from plastic waste that’s been recovered from the environment, often even from the sea itself. The different textures and shades of white enabled me to create a varied work that, despite the almost monochromatic tones, conjures a diverse range of tactile sensations. The biomorphic modular composition evokes skeletons of sea creatures that appear to have been deposited onto the rocks by a wave and left there to wither in the blazing Australian sun.”

More than 4 400 organisations, companies and individuals submitted comments and information on the proposal to restrict per- and polyfluoroalkyl substances (PFAS) in the European Economic Area.

At the end of the consultation on 25 September, ECHA had received more than 5 600 comments from more than 4 400 organisations, companies and individuals.

The comments will be checked by ECHA's scientific committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC), and those providing relevant evidence-based information will be considered in the opinion making process.

The five countries who prepared the initial proposal will also review the consultation input and may update their initial proposal based on it.

Many comments submitted during the consultation are already published on ECHA’s website. Information indicated as confidential by the consultee is not made public. Comments received very close to the deadline are currently being processed and will be published shortly.

Next steps
RAC and SEAC are evaluating the proposed restriction and considering the relevant information received through the consultation. The committees develop their independent, scientific opinions over a series of meetings, where draft opinions are discussed. Attention is given to all aspects and impacted sectors.

ECHA will deliver the final opinions to the European Commission in the shortest possible timeframe, while ensuring proper scrutiny by the scientific committees. Once the committees adopt their opinions, they will be communicated to the public.

The Commission, together with the EU Member States, will decide on the restriction.

Background
The restriction proposal was prepared by authorities in Denmark, Germany, the Netherlands, Norway and Sweden. It was submitted to ECHA on 13 January 2023. It aims to reduce PFAS emissions into the environment and make products and processes safer for people. The six-month consultation ran from 22 March to 25 September 2023.

Further information
•    Consultation comments
•    Restriction on the manufacture, placing on the market and use of PFAS
•    Topical page on PFAS
•    REACH restriction process

Der Bundesverband Medizintechnologie (BVMed) begrüßt die Entscheidung der EU-Kommission, Medizinprodukte wie aufsaugende Inkontinenzhilfen von den Kriterien des EU-Ökolabels für absorbierende Hygieneprodukte nach der europäischen Ökodesign-Verordnung auszunehmen. Der BVMed hatte sich in einer Stellungnahme aus April 2023 dafür ausgesprochen, Medizinprodukte vom Anwendungsbereich auszunehmen und „aufsaugende Inkontinenzprodukte“ aufgrund ihrer medizinischen Zweckbestimmung von Hygieneprodukten abzugrenzen, um die Patient:innen-Versorgung nicht zu gefährden. „Medizinprodukte unterliegen bereits einer sehr strengen sektoralen Regulierung. Es ist gut, dass die EU-Kommission bei Güterabwägungen der Versorgung von Patient:innen mit notwendigen Medizinprodukten ein hohes Gewicht einräumt“, kommentiert BVMed-Geschäftsführer und Vorstandsmitglied Dr. Marc-Pierre Möll.

Der BVMed unterstützt die Zielsetzung der EU-Kommission, die ökologische Nachhaltigkeit von Produkten über ihren gesamten Lebenszyklus zu steigern. „Die Medizintechnik-Branche ist sich ihrer gesellschaftlichen Verantwortung bewusst und arbeitet bereits jetzt intensiv daran, die nachteiligen Auswirkungen ihrer Produkte in Bezug auf die Umwelt zu minimieren, ohne die Funktionalität und Sicherheit in der Versorgung der Patient:innen zu gefährden“, heißt es in der BVMed-Stellungnahme. Wichtig sei, dass die Versorgung und Sicherheit der Patient:innen durchgängig sowie vollumfänglich gewährleistet seien und es zu keinen Unterbrechungen der Versorgung durch Produktengpässe komme.

Das Inverkehrbringen von Medizinprodukten ist über die EU-Medizinprodukte-Verordnung (MDR) geregelt. In dieser sektorspezifischen Regelung sind umfangreiche Voraussetzungen für die Sicherheits- und Leistungsanforderungen von teilweise lebensnotwendigen Produkten für die Gesundheitsversorgung festgelegt.

Rechtsakte, wie unter anderem die Verordnung über Ökodesign, können zu Änderungen von Produkten oder deren Bestandteilen führen und somit neue und langwierige Konformitätsbewertungsverfahren nach sich ziehen, sofern Alternativmaterialien überhaupt vorhanden sind. Dafür müssen umfangreiche Tests durchgeführt und zusätzliche klinische Daten erhoben sowie die komplette Produktdokumentation überarbeitet werden. Dieser Prozess dauert erfahrungsgemäß mehrere Jahre, abhängig von der vorgenommenen Änderung. Allein die Zertifizierung eines Medizinprodukts durch eine Benannte Stelle dauert im Zuge der MDR aktuell durchschnittlich 18 Monate.

Erschwerend kommt hinzu, dass bereits jetzt aufgrund der Implementierung der MDR Kapazitätsengpässe bei den Benannten Stellen bestehen, die die Patient:innen-Versorgung mit sicheren und bewährten Medizinprodukten gefährden. „Diese Situation verschärft sich mit jeder Änderung der regulatorischen Anforderungen, die die Neubewertung von Produkten durch Benannte Stellen erforderlich macht“, so der BVMed.

BVMed-Nachhaltigkeitsexpertin Clara Allonge: „Um mit der Ökodesign-Verordnung einen robusten Rahmen für eine erfolgreiche europäische Nachhaltigkeitsinitiative zu schaffen, ist entscheidend, die branchenspezifischen Besonderheiten, die medizinischen Zweckbestimmungen und die Sicherstellung der Gesundheitsversorgung bei der Ausgestaltung auch künftig zu berücksichtigen.“

Der BVMed repräsentiert über 300 Hersteller, Händler und Zulieferer der Medizintechnik-Branche sowie Hilfsmittel-Leistungserbringer und Homecare-Versorger. Die Medizinprodukteindustrie beschäftigt in Deutschland über 250.000 Menschen und investiert rund 9 Prozent ihres Umsatzes in Forschung und Entwicklung. Der Gesamtumsatz der Branche liegt bei über 38 Milliarden Euro, die Exportquote bei 67 Prozent. Dabei sind 93 Prozent der MedTech-Unternehmen KMU. Der BVMed ist die Stimme der deutschen MedTech-Branche und vor allem des MedTech-Mittelstandes.