Major Reforms to European Medical Device Regulations: What You Need to Know
The EU Parliament and Council Can Make European Healthcare Strong and Sustainable
AMDR welcomes the European Commission’s proposed reforms to Article 17 of the EU Medical Device Regulation (MDR). Although the Commission’s proposal must undergo review, amendment, and adoption by the European Parliament and Council before it becomes law, the current text would:
- Restore the EU’s Single Market and harmonized regulatory principles with respect to single-use 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 supply chains and should lower cost and create sustainable manufacturing jobs in Europe.
- Align EU policy with the stated desires of many European clinicians and clinical societies.
AMDR invites healthcare and policy stakeholders in Europe and beyond to review the proposed reforms and why they are necessary—and a few critical questions we have about them.
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. The EU currently describes 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 CS pathway under the proposed Article 17(4). AMDR is seeking clarification and supports the continued availability of the CS pathway. The CS pathway, built largely on a long-established regulatory framework that existed in Germany, has served as an effective system ensuring safe, regulated reprocessing for years.
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.
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.
“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…”
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 definition is similar to other reprocessing regulations that preserve patient safety around the world.
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.
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. AMDR is exploring the possibility of exempting the proposed 17(3) and 17(4) from this long-term timeframe.
Conclusion
AMDR believes the Commission’s proposed replacement of Article 17 delivers balanced, precedented solutions. 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.
We urge the European Parliament and the Council to preserves these strengths of the Commission’s proposal as it advances through the legislative process.