Association of Medical Device Reprocessors
AMDR
The Association of Medical Device Reprocessors (AMDR) is the global trade association representing professional, regulated medical device reprocessing and remanufacturing companies.
ID: 884250338262-72
Lobbying Activity
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
18 Sept 2025
The Association of Medical Device Reprocessors, AMDR, respectfully submits feedback with regard to Article 17, or the single-use device reprocessing provisions. Consistent with this call for evidences objectives, we strongly urge the Commission to recommend a simplification of Article 17.1 to reduce the needless and disproportionate burden placed on innovative, circular reprocessed or remanufactured devices. Article 17.1 should be revised to strike the ability of Member States to opt out of allowing otherwise EU MDR compliant, CE marked, reprocessed and remanufactured medical device. This places an undue burden on reprocessors who, by definition, have demonstrated their devices are safe and effective by meeting the conformity assessment and all other EU MDR requirements. The existing Article 17.1 is anticompetitive, violates the free movement of goods, and undermines what it means to achieve a CE mark. Further, 17.1 has created fragmentation, when one of the stated goals of having a single, EU wide regulation is to have a single, harmonized market. Allowing Member States to block a CE marked product is unprecedented and fragments the single market. Please find attached our position paper and proposed simplification amendments.
Read full responseResponse to Consumer Agenda 2025-2030 and Action Plan on Consumers in the Single Market
30 Jul 2025
AMDR's two page statement on the urgent need to remove a needless restriction in the EU Medical Device Regulation is in the attached PDF. Thank you for this opportunity.
Read full responseResponse to EU rules on medical devices and in vitro diagnostics - targeted evaluation
17 Mar 2025
On behalf of the Association of Medical Device Reprocessors (AMDR), the global non-profit trade association representing the regulated medical device reprocessing and remanufacturing industry, we appreciate the opportunity to contribute to the targeted evaluation of the EU Medical Device Regulation (MDR). AMDR strongly supports the Commissions objective of a robust, sustainable, and effective regulatory framework that enhances patient safety, market access, and environmental sustainability. However, Article 17 of the MDR remains a major regulatory barrier that contradicts the Commissions circular economy goals, undermines the single market, restricts sustainable medical device solutions, and exacerbates supply chain vulnerabilities. The "opt-in" provision in Article 17 in particular has led to fragmented national regulations, discouraging hospitals from adopting safe, effective, and environmentally sustainable remanufactured medical devices. This structure undermines the MDRs harmonization goals and blocks access to CE-marked remanufactured devices, despite their compliance with all regulatory standards. The Commissions impact assessment highlights the need to evaluate MDRs effectiveness, efficiency, relevance, and coherence, particularly regarding device availability, SME burdens, and alignment with EU environmental policy. Article 17 fails in these areas: It restricts the availability of devices, preventing hospitals from using remanufactured devices that meet EU safety and performance requirements. It burdens SMEs by creating regulatory uncertainty and legal fragmentation, increasing compliance costs, and deterring investment in sustainable medical technologies. It conflicts with EU environmental and circular economy goals by preventing Member States from fully adopting a proven, low-emissions solution for healthcare. Recommendations for Reforming Article 17 To align MDR with its stated objectives, AMDR urges the Commission to: Eliminate the "opt-in" provision (Article 17.1) to ensure consistent access to CE-marked remanufactured devices across all Member States. Allowing Member States to arbitrarily prohibit the sale of CE-marked remanufactured devices violates EU law on free movement of goods and creates unnecessary fragmentation. Require that Member States allowing Common Specification (CS) reprocessing (Article 17.3) also allow CE-marked remanufactured devices, ensuring regulatory consistency. Encourage Notified Bodies to certify CS reprocessing, as no such bodies currently do, leaving hospitals without compliant pathways. Remove unnecessary and restrictive provisions, (Article 17.6, 17.9), which impose a higher standard on remanufactured devices than original ones, without scientific or medical justification. The Need for Immediate Action Prior Commission studies confirm the MDRs implementation challenges, demonstrating the urgent need for reform. The U.S., Canada, the UK, and Japan have successfully integrated remanufactured medical devices into their regulatory frameworks, while the EU is falling behind. As Europe seeks to enhance healthcare resilience, reduce environmental impact, and create a more efficient and harmonized regulatory system, reforming Article 17 is essential. AMDR urges the Commission to align MDR policy with its sustainability and economic goals by removing unnecessary regulatory barriers to remanufacturing. For further details, please see AMDRs full position paper. We welcome the opportunity to discuss these recommendations in more detail. Sincerely, Daniel J. Vukelich, Esq. President and CEO Association of Medical Device Reprocessors (AMDR) DVukelich@AMDR.org
Read full responseMeeting with Pernille Weiss-Ehler (Member of the European Parliament)
10 Jan 2024 · Medical Device Reprocessing and EU MDR
Response to Single Market Emergency Instrument (SMEI)
11 May 2022
Please see the attached comments from the Association of Medical Device Reprocessors
Read full responseResponse to Promoting sustainability in consumer after-sales
4 Apr 2022
The Association of Medical Device Reprocessors, representing the regulated, commercial medical device reprocessing and remanufacturing industry, respectfully submits the attached comments promoting reuse and repair for "single-use" medical devices. We appreciate your consideration and look forward to working with the Commission to reduce barriers and promote incentives to expedite a more circular economy for healthcare products.
Read full responseResponse to Sustainable Products Initiative
16 Nov 2020
The Association of Medical Device Reprocessors (AMDR) appreciates the Commission’s efforts to promote a cleaner and more competitive Europe. We welcome the opportunity to provide feedback to the Inception Impact Assessment on the Sustainable Products Initiative.
- AMDR strongly agrees with the Commission’s aim to widen the scope of the existing EcoDesign Directive beyond energy related products.
- We urge the Commission to include health care products and consumers within the scope of work when addressing the Sustainable Products Initiative. We look forward to the adoption of overarching product sustainability principles and hope they can be applied to health care products
- We further hope the Commission’s efforts will create manufacturer incentives in the health and medical markets to make products used in hospitals and surgical centers more sustainable, including incentivizing and brining awareness to medical device remanufacturing. We encourage the Commission’s consideration of tools to make producers responsible for providing more circular products and intervention efforts aimed at preventing waste.
- We hope the Commission’s efforts will bring attention to the “take-make-use-dispose” of culture in health care and specifically, decreasing medical product lifespans. We hope the Commission’s efforts will educate health care consumers on specific tactics manufacturers use to promote linear production and consumption rather than more sustainable practices. We support mandatory sustainability labeling or disclosure or at least promotion of products that are environmentally preferrable. We support the development of Commission guidance on promoting more circular products in public procurement including potential minimum requirements for product sustainability when the taxpayer is ultimately responsible for absorbing costs.
- We hope the Commission’s efforts in regard to the Sustainable Products Initiative will provide a consistent, reliable mechanism for health care consumers to easily identify products with the lowest environmental footprint. And,
- We hope the Commission will seek to harmonize medical device manufacturer and remanufacturer requirements so as to remove the current additional obstacles/disincentives to environmentally preferrable remanufactured product.
Below and attached, AMDR provides further background information on the need to include health care in the scope of the Product Sustainability Initiative, an overview of remanufactured medical devices, and a discussion of current challenges to greater adoption of circular technologies in the health sector.
AMDR members, located in Europe and the United States, are professional medical device reprocessing and remanufacturing companies, subject to the European Union’s Medical Device Regulation’s (MDR) (2017) requirements, ensuring that remanufactured medical devices meet the same safety and efficacy standards as original equipment. Specifically, Article 17 of the EU MDR sets forth requirements for “single-use” device (SUD) reprocessing and requires commercial firms to meet manufacturer standards, thus adoption of the term “remanufactured” in Europe. AMDR members are both stand alone, independent companies and subsidiaries of original equipment manufacturers (OEMs).
Our detailed comments can be found in the attached document.
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