Major Reforms to European Medical Device Regulations: What You Need to Know
The EU Parliament and Council Can Advance Strong and Sustainable Healthcare
The Association of Medical Device Reprocessors (AMDR) welcomes the European Commission’s proposed reforms to Articles 17 and 61 of the EU Medical Device Regulation (MDR). If adopted by the European Parliament and Council, the Commission’s proposal will:
- Restore the EU’s Single Market and harmonized regulatory principles with respect to “single-use” medical devices (SUDs).
- Align the EU MDR with proven frameworks that have succeeded in other jurisdictions for decades.
- Encourage greater adoption of reprocessed and fully refurbished devices, which enhance the circularity, affordability, and resilience of healthcare.
- Put in place stringent, but reasonable and pro-competitive clinical evaluation procedures.
However, AMDR urges Parliament and Council to make one amendment to the proposal:
- Explicitly preserve the Common Specifications (CS) pathway for SUD reprocessing, provided that the reprocessing meets specific compliance and regulatory requirements.
AMDR supports the adoption and implementation of this proposal—with this targeted amendment—so that the EU may enjoy the benefits of reprocessed and refurbished SUDs and align with the stated desires of its clinicians and clinical societies.
Note on terminology: In EU regulatory terms, “reprocessing” does not refer exclusively to regulated SUD reprocessing, but also to in-house sterilization of reusable devices in hospitals. Currently, Notified Bodies often describe regulated SUD reprocessing as “remanufacturing,” while the proposed reforms would use the term “full refurbishing.” Please see AMDR’s glossary of terms for more information.
What Are the Proposed Reforms?
The Commission’s proposal would reform much of the MDR, but only Article 17 governs SUD reprocessing. Here is the text of the new Article 17 under the current proposal.
A device shall only be intended for single-use where the manufacturer, in light of the design, construction, material, chemical, physical and biological properties of the device, cannot ensure that the device continues to meet the relevant safety and performance requirements when reused in accordance with its intended purpose after appropriate reprocessing. The manufacturer’s justification of an indication of single use shall be part of the technical documentation referred to in Annex II.
If the device is not intended for single-use, the manufacturer shall provide information about the appropriate reprocessing process for allowing reuse in the instructions for use in accordance with Annex I, Section 23.4, point (n).
Single-use devices and devices that cannot be further reprocessed may be subject to full refurbishing within the meaning of Article 2(31). The natural or legal person that carries out the full refurbishing shall be considered as the manufacturer of the fully refurbished device.
The Commission may adopt, in accordance with Article 9(1), CS on general requirements regarding reprocessing of devices or fully refurbishing of single-use devices.
Note: Some stakeholders have expressed uncertainty about the status of the CS pathway under the proposed Article 17(4). AMDR supports the continued availability of the CS pathway—please see the ‘Requested Amendment’ section below for more details.
AMDR’s Position: Why We Support the Proposed Reforms
For years, AMDR joined many European clinicians, researchers, and policymakers to advocate reforming the EU MDR. The Commission’s proposal achieves critical goals outlined in our previous position paper and policy agenda.
Under the current MDR, Article 17 introduces an “opt-in” system that allows Member States to ban or restrict the use of CE-marked reprocessed SUDs within their territories. As AMDR has documented, this approach undermines regulatory harmonization and creates a de facto trade barrier—exactly what CE marking and the EU Single Market is supposed to prevent.
In its study on the implementation of Article 17 in the EU medical devices market, the Commission addressed the shortcomings of this regime:
“The current regulatory framework seems to be…leading to potential confusion and dissatisfaction among stakeholders. [Healthcare institutions and manufacturers] reported a lack of interest in reprocessing due to the diversity and complexity in the national implementations of the regulations in various Member States, in other words, the lack of a common EU-wide approach.”
In addition to undermining a circular industry, regulatory fragmentation threatens the integrity of the CE mark and the regulatory authority of the EU itself. For a product to receive a CE mark, it must meet stringent, evidence-based, safety and performance standards. To allow Member State officials to override that judgment in the case of fully refurbished SUDs contradicts EU principles of unified law.
The Commission’s proposal omits the “opt-in” provision, or any other national-level gatekeeping mechanism, and replaces it with a unified, EU-wide framework—thereby upholding the regulatory and market integration on which the EU was founded.
Article 17(3) of the Commission’s proposal returns fully regulated SUD reprocessing to the established concept of “full refurbishing,” and appropriately treats any entity that carries out such refurbishing as manufacturers. This will entail holding full refurbishers to equivalent safety and performance standards as original manufacturers.
AMDR agrees that entities carrying out full refurbishing and placing devices on the market should be regulated as manufacturers. The MDR would thus align with similar regulatory frameworks that have preserved patient safety for more than 25 years around the world—and keep all pathways for selling CE-marked devices clear, consistent, and accountable.
BioMedical Alliance in Europe:
“For certain types of devices that are intended for single use, safe reprocessing and reuse is possible and can reduce waste and costs in the healthcare system. In the current situation member states decide at national level if they allow reprocessing of single use devices, leading to a fragmented approach across the EU. Under the revision proposal this discretion is removed, and there is an additional responsibility that is put on the manufacturer to justify why a device is single use.”
“The current regulatory framework seems to be challenging with unclear policies and varying interpretations, leading to potential confusion and dissatisfaction among stakeholders. [Health institutes and manufacturers] in particular reported a lack of interest in reprocessing due to the diversity and complexity in the national implementations of the regulations in various Member States, in other words, the lack of a common EU-wide approach.”
European Society of Cardiology:
“Device reprocessing can reduce costs and environmental impact, while impacting positively on supply chain security, and it has been proven as an effective strategy to reduce the carbon footprint of healthcare. According to Article 17 of MDR, reprocessing of single-use devices is possible only if permitted by national law…The European Commission should explore actions to promote a harmonized approach to the safe reprocessing of medical devices across EU member states considering its potential in the reduction of their environmental impact while maintaining patient safety and regulatory compliance.”
“[The] European Union, through its [MDR], have explicitly allowed and set rules for reprocessing…However, in Europe, national law still prevails, leading to inconsistencies in the regulation and practice of reprocessing across the continent. Currently, reprocessing is allowed in some European countries…whereas it is illegal in [others]…The French ban on reprocessing is difficult to understand at a strictly rational level, given that numerous medical societies are in favour of the practice, which offers economic, environmental and strategic advantages.”
French and British clinicians:
“Many European nations…have also embraced [reprocessed] devices. However, in the EU, the MDR only allows [reprocessing] when permitted by national law within individual Member States…This ‘opt-in’ model does not incentivise countries to adopt the practice and adds extra regulatory hurdles before they may do so. As a result, in some European countries, concerned healthcare providers and other industry stakeholders must often raise their voices to advocate change in linear, outdated, or stagnant national policies.”
“Legislative and regulatory support was found vital. Stakeholders advocated for alignment with European Union regulations and modifications to the [MDR] to permit reprocessing of single-use devices.”
“Though intended to harmonize medical device legislation, the implementation of Article 17 varies considerably across Member States. Differing national policies on [SUD] reprocessing under MDR results in a complex regulatory landscape across [Europe] and limits potential cost savings for several Member States’ healthcare systems. In countries where reprocessing is strictly prohibited, many cardiologists advocate for a more permissive approach…”
The proposed Articles 17(1) and 17(2) would require manufacturers to justify SUD labeling and to provide reprocessing instructions for reusable devices. These measures will encourage safe reuse, reduce unnecessary waste, and align with broader EU objectives on sustainability and the establishment of a circular economy. This is particularly urgent given ongoing planetary, epidemiological, trade, and geopolitical pressures.
AMDR’s Requested Amendment: Preserve CS Reprocessing
AMDR urges Parliament and the Council to explicitly preserve the CS pathway for SUD reprocessing—provided that the reprocessing complies with CS adopted by the Commission, compliance is certified by a notified body, and the reprocessed SUD is not being “placed on the market” (e.g., it remains the property of the hospital and is being serviced by a third-party).
This successful service-based model must not be inadvertently eliminated. Under the current EU MDR, many member states have adopted and relied on this regulatory pathway, and the Commission has already adopted extensive CS (2020/1207) as a delegated act. AMDR seeks to maintain that established circular strategy.
The CS pathway—built largely on a long-established regulatory framework that existed in Germany—has effectively ensured safe, regulated reprocessing for years. Many member states have elected to regulate reprocessing under the delegated act CS pathway. AMDR strongly supports preserving this model for the reprocessing of SUDs wherein it complies with CS and is certified by a notified body.
As currently drafted, however, the Commission’s proposal only addresses the “placing on the market” of fully refurbished SUDs. But CS reprocessing includes service-based models in which SUDs are not “placed on the market,” such as third-party reprocessors acting on behalf of hospitals in servicing hospital owned equipment.
AMDR encourages Parliament and the Council to explicitly address this in the legislative text by adding a new Article 17(5). The text should clarify that SUD reprocessing shall be permitted under CS provided that the reprocessing complies with the CS already adopted by the Commission (Implementing Regulation 2020/1207 of 19 August 2020) and is certified by a notified body.
This approach would preserve the long-standing distinction between (1) full refurbishing for market placement and (2) CS-based SUD reprocessing carried out as a service for a health institution. That distinction is not a relaxation of safety standards. On the contrary, it preserves a proven, highly regulated pathway that enables safe reprocessing while avoiding the unnecessary elimination of an important circular-economy model currently relied upon by European hospitals.
AMDR encourages the Parliament and Council to adopt the following new Article 17(5):
5. By way of derogation from paragraph 1 of this Article, the reprocessing of single-use devices according to common specifications may continue to be permitted provided that the following cumulative conditions are met:
(a) the reprocessing is performed in accordance with the common specifications published in Implementing Regulation (EU) 2020/1207 of 19 August 2020; and
(b) compliance of the reprocessing with the common specifications is certified by a notified body.
Questions & Answers
As the Commission’s proposal undergoes the EU legislative process, we anticipate that healthcare, reprocessing industry, policy, and other stakeholders will have questions. Here is what we know so far.
We want to hear your thoughts, too—if you have insights, or your questions are not listed, please contact AMDR.
Not yet. The Commission’s proposal must undergo the EU legislative process, including parallel review, amendment, and negotiation by the European Parliament and the Council. If these bodies reach agreement, the law is passed.
Yes. If amended, there will be important changes to terminology. The proposed changes to Article 17 will continue to permit and regulate SUD reprocessing, including by third-parties. The MDR will refer to SUD reprocessing as “full refurbishing” and the entities carrying it out as “full refurbishers.” It will refer to other forms of device reuse, including hospital reuse, as “reprocessing.”
Yes. According to the MDR, “full refurbishing” involves the restoration of a used medical device to a state that conforms with safety and performance requirements, enabling it to be placed back on the market with a new life. This framework is similar to other reprocessing regulations that preserve patient safety around the world.
Please see AMDR’s glossary of terms for more information and specific regulatory definitions.
Yes. The definition of “manufacturer” includes any full refurbishment, and all manufacturers must meet the requirements of the MDR to obtain a CE mark. Full refurbishing is manufacturing and subject to the exact same controls.
Please see AMDR’s glossary of terms for more information and specific regulatory definitions.
Does the proposed MDR allow individual Member States to establish separate reprocessing regulations?
No. The proposal omits national-level mechanisms that would allow Member States to establish separate or stricter reprocessing regulations, or require them “opt in” to allow reprocessing. The intent of the Commission is to create a single, stringent, harmonized framework for reprocessing regulations across the EU, in keeping with the principles of unified law and a single market that the MDR is supposed to uphold.
Yes. We believe the intent of the Commission is to encourage more device reprocessing, full refurbishing, and other sustainable practices. As such, the proposed 17(1) establishes that device manufacturers may only apply the SUD label if they cannot demonstrate that the device cannot meet relevant safety and performance requirements when reused. 17(2) further mandates that manufacturers must provide reprocessing instructions for non-SUDs.
No. The added burdens placed on manufacturers are intended to prevent overzealous application of the SUD label. Nothing precludes any entity from reprocessing a SUD so long as the entity complies with pertinent regulatory requirements.
If approved, the proposed amendments to Article 17 will take effect five years from passage.
Conclusion
AMDR believes the Commission’s proposed replacement of Article 17 delivers balanced and precedented solutions in key respects. The new Article 17 would restore the integrity of the Single Market and the authority of the CE mark, align with proven regulatory models, and encourage circular economy practices without weakening MDR standards.
At the same time, the final text should be amended to preserve and clarify the CS pathway for SUD reprocessing, provided the reprocessing complies with CS adopted by the Commission by delegated act and is certified by a notified body.
We therefore urge the European Parliament and Council to adopt the Commission’s proposal—with a targeted amendment to preserve successful CS pathways—so that the EU can preserve and strengthen effective, safe, and sustainable pathways for the reprocessing and full refurbishing of SUDs.