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SPECTARIS Deutscher Industrieverband für Optik, Photonik, Analysen- und Medizintechnik e.V.

SPECTARIS

SPECTARIS is a German association representing SMEs in medical and precision technologies.

Lobbying Activity

Meeting with Tiemo Wölken (Member of the European Parliament) and MedTech Europe

21 Jan 2026 · MDR/IVDR

Meeting with Vita Jukne (Cabinet of Commissioner Jessika Roswall)

15 Dec 2025 · Upcoming PFAS restriction

Meeting with Olivér Várhelyi (Commissioner) and

18 Nov 2025 · Medical device review

Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

6 Oct 2025

SPECTARIS begrüßt die Initiative der Europäischen Kommission zur gezielten Revision der Verordnungen (EU) 2017/745 (MDR) und (EU) 2017/746 (IVDR). Die medizintechnische Industrie in Deutschland steht für Innovation, Qualität und Versorgungssicherheit. Die aktuellen regulatorischen Rahmenbedingungen gefährden jedoch zunehmend die Verfügbarkeit von Medizinprodukten und In-vitro-Diagnostika in Europa. Eine gezielte Revision ist dringend erforderlich, um die ursprünglichen Ziele der Verordnungen Sicherheit, Innovationsförderung und ein funktionierender Binnenmarkt wieder zu erreichen. Besonders betroffen sind kleine und mittlere Unternehmen (KMU), die das Rückgrat der europäischen Medizintechnikbranche bilden. Sie stehen für über 90 % der Unternehmen in diesem Sektor und sind maßgeblich an der Entwicklung und Bereitstellung innovativer Produkte beteiligt. Die MDR und IVDR stellen KMUs jedoch vor erhebliche Herausforderungen: hohe Kosten für Konformitätsbewertungen, komplexe Anforderungen an die klinische Evidenz und mangelnde Planbarkeit gefährden ihre Wettbewerbsfähigkeit und Innovationskraft. Daten aus einer aktuellen Verbändeumfrage zeigen einen deutlichen Rückgang der Innovationskraft deutscher Unternehmen: Unternehmen haben ihre Forschungs- und Entwicklungsprojekte aufgrund der MDR/IVDR reduziert und neue Produkte werden zunehmend zuerst in anderen Märkten, insbesondere in den USA, eingeführt. SPECTARIS schlägt daher nachfolgende Änderungen in Bezug auf die MDR vor, welche geeignet sind, die ursprünglichen Ziele der Verordnung wiederherzustellen und die Wettbewerbsfähigkeit der deutschen und europäischen Medizintechnikbranche zu sichern. Die vorgeschlagenen Anpassungen sollen für mehr Planbarkeit sorgen, die Anforderungen verhältnismäßig gestalten und den bürokratischen Aufwand reduzieren ohne dabei die Patientensicherheit zu beeinträchtigen.
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Response to EU label on product durability and EU notice on consumers’ legal guarantee rights

24 Jul 2025

Preliminary Remarks SPECTARIS, the German industry association for optics, photonics, analytical and medical technology, generally supports transparency and sustainability but sees significant challenges in the planned EU requirements for durability labelling and guarantee informationparticularly concerning spectacle frames, spectacle lenses, and ready readers. These and other products, classified as medical devices, are already subject to strict regulatory standards ensuring quality and patient safety and are often supported by long-term, personalised care from healthcare providers. Additional labelling obligations would create unnecessary bureaucracy within these established care structures without delivering meaningful benefits to consumers. According to the proposed regulation, consumer products would need to display standardized information on statutory warranties and manufacturer guarantees visibly at the point of sale, at a minimum in A4 format, and up to A1. This information would also need to be published online, with further details accessible via QR code. In cases where a manufacturer offers a free-of-charge guarantee, an additional label measuring at least 9.5 x 10 cm would be required. These measures would result in a substantial administrative and legal burdenespecially for small and medium-sized enterprisesand disregard the ongoing development of a unified EU digital product passport, which aims to consolidate all relevant product data in one digital format. Furthermore, the added large-format labels would significantly increase paper usage, directly contradicting the sustainability goals of the EU Green Deal. SPECTARIS therefore urges restraint in introducing fragmented information obligations, calls for an exemption for medical devices, and strongly advocates for digital, practical, and sustainable solutions that support innovation and competitiveness. Our main arguments can be found in the attached position paper.
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SPECTARIS urges medical device exemptions from product destruction reporting

9 Jul 2025
Topic — The EU is requiring companies to disclose information regarding unsold consumer products they destroy.
Message — SPECTARIS requests exemptions or specific rules for medical devices like eyewear and bandages. They argue these products are discarded based on safety standards rather than commercial reasons.12
Why — This allows companies to maintain strict safety protocols without facing public pressure regarding disposal.3
Impact — Environmental transparency suffers if large volumes of medical waste remain unreported to the public.4
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

21 Mar 2025

The German Industry Association SPECTARIS welcomes the opportunity to give input to the targeted evaluation. The German medical technology industry has an annual turnover of circa 38 billion Euro and employs over 161.400 people, over 90% of companies are Small or Medium Enterprises. In short: Medical Devices and IVDs to ensure the health and safety of citizens are an essential driver of industry. Over the past couple of years, it has become clear that while well-intentioned and conceptually sound, the medical device frameworks have multiple egregious shortcomings and there is an urgent need for legal measures to rectify them. Two years ago, we conducted a survey on the effects of the IVDR and MDR on Industry with shocking results: 53% of manufacturers are planning to discontinue products, product lines or their entire range. In nearly 20% of these cases, there is no equivalent alternative for these products. Our survey has found that SMEs are more likely to be negatively impacted by these burdens, with 67% reporting discontinuation. 91% of manufacturers cited increased certification costs and 74% cited bureaucracy as the reason to discontinue products. The Medical Device frameworks need to be adjusted to foster innovation and ensure competitiveness. This means cutting costs and reducing bureaucracy. Some of the areas we suggest looking closely at: Petter planning of the certification process to ensure predictability Transparency and reduction in relation to costs and fees Recertification and reassessment of certificate validity Proportionate assessment of clinical evidence / performance Establishment of good governance practices including: o Elimination of redundancies in documentation o Establishing an accountable Governance Structure o Transparency for Guidelines o Structured Dialog with Notified Body Pathways in support of innovation Measures in support of SMEs Digitization, Classification rules, coherence with overlapping legislation and change notifications
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Response to Implementing regulation for electronic instructions for use for medical devices

21 Mar 2025

SPECTARIS strongly supports the European Commissions initiative to update EU regulation 2021/2226. This proposal is a significant advancement as electronic Instructions for Use (eIFU) will enhance accessibility, searchability, and flexibility for medical device professionals and stronly supports the aspects of sustainability, resource and climate protection and the necessary digitalization in the EU for global competitiveness. We believe that the draft effectively meets its intended objectives. With the broadened scope of EU regulation 2021/2226, a variety of mass products intended for professional use can now also benefit from eIFUs. Consequently, certain sections in the text require clearer phrasing to prevent any potential misunderstandings.
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SPECTARIS Urges Longer Transitions for Lead Use Exemptions

10 Feb 2025
Topic — EU consultation on hazardous substance exemptions for lead in metal alloys.
Message — SPECTARIS requests extending transition periods for non-renewable exemptions to 18-36 months. They advocate for maximizing the duration of renewable exemptions and including medical devices. The group recommends avoiding unnecessary subdivisions of exemptions to reduce complexity.123
Why — This would allow companies sufficient time for complex testing and mandatory re-certification.45
Impact — Medical and research sectors risk supply shortages of essential high-tech equipment.67
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High-tech association SPECTARIS urges longer lead exemption transitions

10 Feb 2025
Topic — This consultation evaluates RoHS exemptions for lead in electrical and electronic components.
Message — The association recommends extending transition periods to 18-36 months for non-renewable exemptions. They demand maximizing exemption durations to accommodate long medical development and validation cycles. The group also advocates for including medical devices and monitoring instruments in exemptions.123
Why — This prevents financial losses and helps companies maintain stable international supply chains.4
Impact — Patients and researchers face supply risks if critical medical or laboratory equipment becomes unavailable.56
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SPECTARIS urges longer transition periods for lead solder exemptions

10 Feb 2025
Topic — The EU is consulting on hazardous substance exemptions for lead in electronic solders.
Message — SPECTARIS requests extending transition periods to at least 18-36 months. They seek additional time for medical devices to accommodate complex safety re-certification processes.12
Why — Companies would avoid high redesign costs and disruptions to international supply chains.34
Impact — Patients and researchers face supply risks for critical medical and analytical equipment.56
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Meeting with Andrea Wechsler (Member of the European Parliament) and FuelsEurope and

4 Feb 2025 · EU Energy and industry policy

Meeting with Andreas Glück (Member of the European Parliament)

15 Oct 2024 · MDR

SPECTARIS seeks simpler F-gas certification and implementation delays

10 Jun 2024
Topic — Revision of minimum certification requirements for refrigeration, heat pumps, and mobile cooling equipment.
Message — The association recommends excluding carbon dioxide and ammonia or merging their certification categories. They propose delaying the new requirements until 2027 to allow sufficient adaptation time. The group also requests restoring exemptions for supervised brazing, soldering, and welding.1234
Why — These changes would reduce compliance costs and prevent redundant training for specialized staff.56
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SPECTARIS Urges Flexibility for Compact F-Gas Equipment Labels

4 Jun 2024
Topic — The European Commission is updating labeling requirements for products containing fluorinated greenhouse gases.
Message — SPECTARIS calls for shorter label text and digital options for small equipment where space is limited. They also request permission to use international GWP standards for exports to avoid confusion.123
Why — This would reduce labeling complexity and costs for manufacturers of small, specialized medical and lab equipment.4
Impact — Service personnel might find safety information harder to access without immediate physical text on equipment labels.5
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Response to Recommendation to monitor outbound investments for further risk assessment

17 Apr 2024

SPECTARIS e.V. welcomes the opportunity to provide feedback on the topic of "investments by EU companies in non-EU countries - monitoring for further risk assessment". In summary, it is evident that non-European foreign investments strengthen prosperity and growth in Europe. There are also many existing instruments, such as export control instruments, for monitoring critical technologies or key industries. The broad scope of the proposed monitoring not only restricts economic freedom but also hinders innovation, thereby enforcing discriminatory practices by third countries. Instead of new bureaucratic requirements, it would be necessary to more effectively integrate existing regulations and monitoring tools in order to improve the conditions of the EU especially by reducing overregulation as an attractive investment location. For the full feedback find the position of SPECTARIS e.V. attached.
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Meeting with Andreas Glück (Member of the European Parliament)

17 Apr 2024 · PFAS

SPECTARIS urges EU to align overlapping reporting regulations

1 Dec 2023
Topic — This consultation seeks to simplify and reduce administrative reporting burdens for companies.
Message — SPECTARIS requests better alignment between different laws to avoid duplicate or contradictory requirements. The Commission should assess how broad cybersecurity and sustainability rules overlap with specific medical regulations.12
Why — Streamlining these requirements would reduce costs that currently act as barriers to innovation.3
Impact — Healthcare providers and patients suffer from complex, overlapping regulations in the medical technology sector.4
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SPECTARIS Demands Medical Device Exemption From Cyber Resilience Act

20 Jan 2023
Topic — The European Commission is setting cybersecurity standards for products with digital elements.
Message — The association wants medical devices fully excluded to prevent regulatory overlap and confusion. They also request increasing the reporting window for security incidents from 24 to 72 hours. Additionally, they call for a staggered implementation to avoid future certification delays.123
Why — Exempting medical devices avoids costly double regulation for already heavily regulated manufacturers.4
Impact — Public security agencies like ENISA would receive slower alerts about active cyber threats.5
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Response to Extension of the transition period for medical devices

18 Jan 2023

At the EPSCO Health Council on December 9, 2022, the Commission had announced to put forward a TARGETED LEGISLATIVE PROPOSAL at the beginning of January 2023 TO ADDRESS the IMMINENT RISK OF SHORTAGES of MEDICAL DEVICES in Europe and the associated risk of a public health crisis, stemming from the Medical Device Regulation (MDR) implementation challenges. SPECTARIS, the German Industry Association for Optics, Photonics, Analytical and Medical Technology, welcomes that the COMMISSION HAS ACTED SWIFTLY to put forward this proposal. The PROPOSED TRANSITIONAL PROVISIONS ARE ESSENTIAL TO AVOID FURTHER SUPPLY SHORTAGES of medical devices that are needed for the smooth functioning of health services in the EU. It is of UTMOST IMPORTANCE that the European Parliament and Council ADOPT THIS LEGISLATIVE PROPOSAL AS QUICKLY AS POSSIBLE to restore an acceptable regulatory pathway that enables all categories of medical devices to remain available to patients and healthcare systems. We trust that the proposed transition periods and timelines have been established in close consultation with Notified Bodies. These will have a pivotal role to ensure a feasible implementation of the proposed provisions and transition of all devices to the MDR, where manufacturers have taken the necessary steps to do so. Furthermore, we trust that a harmonized interpretation will be ensured in close collaboration with all stakeholders involved. SPECTARIS would like to point out that the extended transition periods will not solve the underlying structural problems of the MDR causing product discontinuations and innovation to leave Europe. However, we understand that at this critical moment in time, it is not feasible and this proposal is not intended to address the structural issues arising from the MDR and IVDR. We, therefore, take note of the Commissions commitment expressed in the information note sent to the Council in preparation of the Council meeting (EPSCO) on December 9, 2022 to also CONTINUOUSLY WORK ON REMAINING ACTIONS listed in MDCG guidance 2022-14 as well as further necessary actions co-funded under the EU4Health Programme to start in 2023. We encourage the Commission to undertake a comprehensive evaluation of the MDR and IVDR as soon as possible to further address remaining structural issues. Our members remain fully committed to ensure a successful implementation of the MDR and IVDR and our association stands ready to support and continue to work with EU stakeholders and decision makers.
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Meeting with Andreas Glück (Member of the European Parliament)

18 Jan 2023 · MDR

SPECTARIS urges streamlined rules for European Health Data Space

27 Jul 2022
Topic — The consultation seeks feedback on establishing a secure European Health Data Space.
Message — SPECTARIS requests avoiding regulatory overlaps with existing medical device frameworks. They advocate for equal data access for private research and the use of international cybersecurity standards.123
Why — This approach would prevent excessive regulatory burdens on small and medium-sized enterprises.4
Impact — Public institutions would lose their priority status for accessing and using health data.5
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Spectaris seeks longer F-gas transition for medical equipment

29 Jun 2022
Topic — The EU is reviewing rules for fluorinated greenhouse gases used in refrigeration.
Message — Spectaris requests a transition period until 2030 for medical and laboratory devices. They seek clearer definitions of refrigeration equipment to ensure legal certainty for manufacturers.12
Why — A longer timeline helps manufacturers manage the severe lack of certification experts.3
Impact — Delayed phase-outs mean these greenhouse gas emissions will continue causing climate change.4
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SPECTARIS Urges EU to Ease SME Compliance on Forced Labour

19 Jun 2022
Topic — The EU is consulting on a regulation to ban products made with forced labour.
Message — The association requests a central registry of blocked entities to simplify risk management. They also advocate for desktop reviews and clear customs documentation requirements for importers.123
Why — A central registry would lower audit costs and reduce administrative 'paper war' for small businesses.45
Impact — Forced labour victims may remain unprotected if companies rely on easily faked desktop reviews.6
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Meeting with Andreas Glück (Member of the European Parliament)

9 Jun 2022 · MDR

SPECTARIS urges limited supply chain scope for sustainability rules

23 May 2022
Topic — Consultation on rules for companies to address human rights and environmental impacts.
Message — SPECTARIS recommends limiting due diligence to direct suppliers and removing customer monitoring requirements. They also suggest excluding recycled materials and medical products from the directive scope.1234
Why — Restricting the scope would significantly reduce administrative, personnel, and financial costs for businesses.5
Impact — Victims of human rights abuses lose the ability to sue companies for damages.6
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SPECTARIS urges simpler exemption rules for electronic hazardous substances

14 Mar 2022
Topic — The European Commission is reviewing rules restricting hazardous substances in electrical and electronic equipment.
Message — SPECTARIS wants the exemption process to consider socioeconomic impacts and substitute availability. They also request longer validity and transition periods for highly regulated sectors.123
Why — This would reduce administrative burdens and allow companies to focus on research.45
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Response to Amendment of the Blocking Statute

30 Aug 2021

Wir bedanken uns für die Möglichkeit unsere Stellungnahme abzugeben. Im Anhang und nachfolgend finden Sie eine erste Stellungnahme von SPECTARIS. Deutscher Industrieverband für Optik, Photonik, Analysen- und Medizintechnik e.V. zur Novellierung der EU-Blocking-Verordnung. In den letzten Jahren haben die verschiedenen „Handelskriege“ und ihre Auswirkungen auf die Weltwirtschaft sowie die europäische Wirtschaft stark zugenommen. Unsere Mitgliedsunternehmen sehen sich zunehmend mit Strafzöllen, nicht-tarifären Handelshemmnissen sowie (extraterritorialen) Sanktionen konfrontiert. Gerade die jüngsten extraterritorial wirkenden US-Maßnahmen gegen Russland im Hinblick auf die Pipeline Nord Stream 2 sowie gegenüber Iran, Kuba und nicht zuletzt gegenüber der Volksrepublik China werden für unsere exportstarken Mitglieder zunehmend zu einer Herausforderung im internationalen Handel. Aufgrund der geopolitischen Spannungen und des seit mehreren Jahren schwelenden Handelskonflikts mit den USA setzt die Volksrepublik China seit 2021 ebenfalls auf extraterritorial wirkende Sanktionen, die eine neue Herausforderung für unsere Mitgliedsunternehmen darstellen. Zu befürchten ist außerdem, dass weitere Staaten nachziehen könnten und ebenfalls extraterritorial wirkende Sanktionen verhängen. Der Zugang zu Auslandsmärkten ist für die exportstarken SPECTARIS-Mitglieder essentiell. Unsere Mitglieder erwirtschaften knapp 2/3 ihres Umsatzes im Ausland. In der Folge müssen in unseren Mitgliedsunternehmen verstärkt personelle und finanzielle Ressourcen aufgewendet werden, um zwischen den verschiedenen, sich teilweise widersprechenden, ausländischen Rechtsordnungen zu navigieren und die Einhaltung der verschiedenen Vorschriften sicherzustellen. Protektionistische Maßnahmen einzelner Staaten, aber auch die steigende Anwendung von (extraterritorialen) Sanktionen als Mittel einzelner Staaten, um politische und wirtschaftliche Interessen durchzusetzen, erschweren dabei zunehmend den Marktzugang, den Freihandel und die unternehmerische Freiheit unserer Mitgliedsunternehmen. Um den Produktionsstandort Europa zu sichern und auszubauen, sollte der Einsatz der EU für freien, fairen Handel und den Abbau von Handelshemmnissen weiterhin das Leitprinzip der EU in der internationalen Handelspolitik sein. Allerdings führen der zunehmende Protektionismus und die völkerrechtlich umstrittenen extraterritorialen Sanktionen nachweislich zu starken wirtschaftlichen Folgen für die wirtschaftliche Autonomie von europäischen Unternehmen, wie auch die EU in einer kürzlich veröffentlichten Studie anerkennt. Vor dem Hintergrund, dass immer mehr Staaten sich dem Instrument „extraterritoriale Sanktionen“ bedienen, muss die Europäische Union ein wirksames Gegenwicht und ein deutliches Signal setzen, dass sie in der EU-ansässige Unternehmen vor den schädlichen Auswirkungen von extraterritorialen Sanktionen stärker schützt und Sanktionen anderer Staaten nicht tolerieren wird. SPECTARIS befürwortet daher eine dahingehende Überarbeitung und Schärfung der EU-Blocking-Verordnung. Eine Schärfung der Vorschriften und Überarbeitung der Blocking-Verordnung kann aus Sicht von SPECTARIS jedoch nicht das einzige Instrument sein, um EU-Unternehmen vor den schädlichen Auswirkungen von extraterritorial wirkenden Sanktionen zu schützen. Als begleitende Maßnahme muss die Europäische Union Unterstützungsangebote auf den Weg bringen, um EU-Unternehmen die Fortführung ihrer Geschäfte in von anderen Staaten sanktionierten Zielländern zu ermöglichen. Wichtigstes Instrument sind hier die Schaffung und Etablierung von Zahlungskanälen, die vom Dollar als Leitwährung unabhängig sind. Dies könnte durch eine Stärkung von INSTEX oder durch eine neu geschaffene EU-Exportbank erreicht werden. Unsere Überarbeitungs- und Präzisierungsvorschläge zur derzeitigen Fassung der EU-Blocking-Verordnung sowie die damit einhergehenden Begleitmaßnahmen entnehmen Sie bitte unser ersten beigefügten Stellungnahme.
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Response to Revision of the Machinery Directive

16 Aug 2021

The Commission´s proposal for a regulation of the European Parliament and of the Council on machinery products aims to update the existing Machinery Directive 2006/42/EC in order to “align the Directive with EU harmonised legislation on product health and safety, and tackle the challenges that may arise from technical progress in digitization”. SPECTARIS welcomes this objective. SPECTARIS also strongly supports the aim of the inititative to reduce the administrative burden and additional costs for operators by acknowledging digital forms for documentation. This is also a logical step towards meeting European sustainability goals outlined in the European Green Deal. Nevertheless, SPECTARIS holds the opinion that adjustments to the current draft regulation are necessary. The reasons as well as technical comments and proposed changes are included in the attached file.
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Response to Requirements for Artificial Intelligence

5 Aug 2021

SPECTARIS - the German Industry Association for Optics, Photonics, Analytical and Medical Technology welcomes the Commission´s initiative to lay down harmonised rules on Artificial Intelligence. SPECTARIS agrees with the objectives outlined in the European Commission´s proposal (Artificial Intelligence Act; AIA): to further research and innovation whilst maintaining a high level of safety for EU citizens. However, the planned legislation includes additional regulatory requirements for medical devices by rigidly classifying most medical devices as high-risk AI devices - regardless of their respectively used AI elements and risk class as defined in MDR (Regulation (EU) 2017/745 on medical devices) and IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices). Since applicable law has already set extensive AI requirements for medical devices and software, SPECTARIS would like to highlight a general concern: Parallel and unaligned regulatory frameworks regarding AI components in medical devices and in vitro diagnostics should by all means be avoided. Otherwise it would lead to regulatory overlapping, discrepancies and additional legal uncertainty for medical technology manufacturers. Hence, SPECTARIS recommends further alignment of the proposed AIA with the applicable law for medical devices and in vitro diagnostic as well as necessary additional conceptual clarifications and changes in the AIA. Detailed feedback on key issues are included in the attached position paper.
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Response to Electronic instructions for use for medical devices

25 May 2021

SPECTARIS is the German Industry Association for Optics, Photonics, Analytical and Medical Technology based in Berlin. The association represents 400 predominantly medium-sized German companies. This initiative aims to renew the existing eIFU rules established under Commission Regulation (EU) 207/2012 in order to “reduce the environmental burden and reduce costs for the medical device industry while maintaining or improving the level of safety” - SPECTARIS welcomes this objective. However, the proposed draft legislation does not substiantially renew the existing regulation and does not sufficiently take into account developments over the past years regarding digitalisation as well as the sustainability goals outlined by the Commission. SPECTARIS holds the opinion that fundamental adjustments to the current draft regulation are necessary. SPECTARIS encourages the Commission to enhance the use of eIFU for medical devices – in particular where they are intended for professional users. Users greatly benefit from eIFU as they allow quick and up to date information that can be used and accessed according to individual needs. Worldwide eIFUs are already successfully in use in other jurisdictions. EIFUs have a positive effect on the environment and thus greatly contribute to the Commission’s sustainability goals. The use of eIFU is already consequently incorporated into the revision of other EU legislation, so the existing Regulation 207/2012 should be fundamentally reviewed, too. General remarks outlining the advantages of eIFU as well as more technical comments and proposed changes to the current draft are included in the attached file.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

1 Feb 2021

SPECTARIS is the German Industry Association For Optics, Photonics, Analytical And Medical Technology. The association represents 400 predominantly medium-sized German companies. The consumer optics (ophthalmic optics), photonics, medical technology and analytical, bio and laboratory technology sectors achieved a total turnover of over 73 billion euros in 2019 and employ around 328,000 people. SPECTARIS welcomes the objective of the draft Regulation aimed at strengthening public health crisis preparedness and response within the European Union (EU). However, the planned legislation has far-reaching implications for manufacturers of medical devices and in vitro diagnostics and regulates aspects that are already enshrined in other EU regulations. This relates in particular to the planned expansion of the role of the European Medicines Agency (EMA) as the secretariat for the expert panels under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), as well as its new role as a coordinating body for monitoring and planning availability of medical devices and in vitro diagnostic medical devices in times of crisis. SPECTARIS is of the opinion that significant adjustments still need to be made to the present draft regulation. For further details please see included position paper.
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Meeting with Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska) and MedTech Europe and

5 Sept 2019 · Medical Devices (Mr Bermig attended the meeting organized by Commissioner Oettinger)

Meeting with Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska) and ZVEI e.V. - Verband der Elektro- und Digitalindustrie

20 Jan 2016 · Medical Device Regulation