Draft EU medtech revisions adjust importer and distributor roles to support supply chain resilience

Economic operators beyond manufacturers – importers, distributors and other supply chain participants – play a critical role in the availability and safe use of medical devices and in vitro diagnostics. The Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) provide detailed responsibilities for these operators, but experience since their application, combined with recent supply disruptions, has revealed areas for refinement.

The proposed amendments published by the European Commission on 16 December last year address several areas relevant to supply-chain actors. These include indirect impacts from digitalisation, streamlined repackaging and relabelling rules, enhanced transparency through digital contact information and mechanisms to manage device shortages – including new supply interruption reporting obligations and tools coordinated by the European Medicines Agency (EMA).

Supply chain resilience

The Commission's evaluation of the MDR and IVDR underlined that the MDR and IVDR's complexity and timing challenges have contributed to shortages and potential discontinuations of important devices. At the same time, repeated crises – including Covid 19  and subsequent supply disruptions – have highlighted the importance of resilient supply chains and timely communication of shortages across borders.

A previous regulation (EU) 2024/1860 already partially addressed some of these concerns, by introducing an article 10a (obligations in case of interruption or discontinuation of supply of certain devices) in the MDR and IVDR. The provision created obligations on manufacturers to inform competent authorities and, in some cases, health institutions of planned interruptions or discontinuations of supply for certain devices, with the aim of preventing or mitigating shortages. The present proposal builds on this approach by clarifying digitalisation duties for economic operators and simplifying certain aspects of repackaging and relabelling.

Digitalisation impacts

The proposal broadly proposes that the submission of "information or documents" under each regulation should now take place electronically with a new article 110a in the MDR and 103a in the IVDR (both titled as "submission of information or documents"). This affects importers and distributors insofar as they are required to comply with a range of submissions: for example, as part of their vigilance obligations or market surveillance investigations led by competent authorities.

Annex VI (UDI [unique device identifier] and registration requirements) to both regulations would require economic operators – including importers, suppliers or sterilisers of systems and procedure packs, authorised representatives and manufacturers – to provide digital contact details in the European database for medical devices (Eudamed), building on existing registration requirements. Distributors are not subject to this obligation.

Under the current regulations, importers and distributors should verify that the EU declaration of conformity (DoC) has been drawn up and that the device is accompanied by the appropriate label and instructions for use (IFU). The proposal paves the way for these elements to be provided digitally: the DoC may be made available electronically – including online – subject to appropriate safeguards; labels may be provided in digital form to the extent permitted by implementing rules; and IFUs may be supplied electronically or via a website link, subject to conditions. For importers and distributors, this potential shift means that compliance verification processes are likely to increasingly involve checking digital records and online resources rather than physical documents, with potential adjustments to internal procedures and quality management systems if the proposal is passed into law.

Distributors' sampling

The proposal extends the scope of permitted sampling activities under article 14 (general obligations of distributors) of the MDR and IVDR to include verification of importer compliance.

Under the current rules, distributors may use representative sampling methods to check that devices bear the CE marking, are accompanied by the required manufacturer information, and carry a UDI where applicable. However, sampling has not been permitted by the legislation for verifying that importers have fulfilled their own regulatory duties.

The proposed amendments would allow distributors to apply the same sampling approach to importer compliance checks, reducing the administrative burden while maintaining oversight across the supply chain.

Repackaging and relabelling simplification

The MDR and IVDR address situations where importers or distributors carry out operations such as providing information or translating information supplied by the manufacturer, changing the outer packaging or repackaging devices. Under the current texts, such operations can trigger obligations akin to those of a manufacturer, including the need to obtain a certificate from a notified body for the repackaging or relabelling activities and to provide prior notice to the manufacturer and competent authority.

Stakeholders have argued that, where these operations do not affect the device itself, the notified body certificate and prior notice obligations can be disproportionate, particularly in the context of parallel distribution.

The proposal amends the current text to remove the requirement for a notified body certificate and the prior notice obligation for certain repackaging and relabelling activities, provided specific conditions are met. These conditions include that the operations do not negatively affect the device's original condition, that the device remains in conformity with the regulations and that the economic operator operates under an appropriate quality management system.

By eliminating external certification and formal notification for such routine activities, it is hoped that the amendments would reduce administrative burden on distributors and importers and are expected to facilitate smoother cross‑border flows of devices. In that context, economic operators should still ensure that translated labels and updated packaging are accurate and do not mislead users, as they remain liable under applicable EU and national laws.

Supply interruption or discontinuation

Article 10a of both regulations requires manufacturers of certain devices, particularly those critical for public health, to inform competent authorities and, where relevant, health institutions and other stakeholders of an intention to interrupt or discontinue supply within defined timeframes (generally at least six months in advance).

Under the current system, importers and distributors are expected to relay the information or notification they receive from manufacturers as received, without altering or paraphrasing it, to preserve the integrity of the manufacturer’s message. In the field, practice shows that downstream customers such as hospitals, purchasing groups and wholesalers expect distributors and importers to act as reliable "early warning" conduits.

To support the current mechanism, a central IT tool for the reporting and information exchange under the proposal's amended article 10a would be provided in Eudamed or interoperable with Eudamed. The EMA is tasked by the draft legislation with developing a methodology to identify devices falling within the scope of the reporting obligation and drawing up a list of such devices. The system is expected to be set up, maintained and managed by the Commission, with EMA's cooperation where needed.

Enhanced post-marketing coordination

The Commission's proposed amendments to chapter VII (post-market surveillance, vigilance and market surveillance) of the MDR and IVDR on post marketing workflows are intended to reinforce coordination across the supply chain. The approach builds on the revised post-market surveillance framework, which would reduce periodic safety-update reports frequency and extend certain incident reporting timelines.

The proposal refines the mechanisms for addressing safety issues and other non‑compliances once devices are on the market, in ways that more clearly involve all economic operators. Under the MDR's revised article 95 (procedure for dealing with devices presenting an unacceptable risk to health and safety), when a competent authority identifies an unacceptable risk and sets a deadline for corrective action, importers and distributors – alongside manufacturers and authorised representatives – should ensure that appropriate corrective actions are taken "throughout the Union" for all affected devices they have made available on the market, within that defined period. The proposed change confirms that measures such as withdrawals, recalls or restrictions are expected to be implemented consistently across all relevant Member States, rather than being confined to the territory of the authority that first intervened, although the precise operational approach might depend on how individual authorities apply these provisions in practice.

​For "other non‑compliances" that do not rise to the level of an unacceptable risk, the updated article 97 (other non-compliance) makes it explicit that competent authorities may also address situations where a device or an economic operator does not meet regulatory requirements, which can include cases where an importer or distributor has not fulfilled its MDR or IVDR obligations. Where such issues are not resolved within the deadline set under the legislation, the Member State should take measures on its national market, and the new provision then requires the economic operator to take appropriate corrective action throughout the Union in respect of all affected devices it has made available, unless a competent authority decides to take other measures.

Taken together with the clarified EU‑level review process in article 96 (procedure for evaluating national measures at Union level), these adjustments are intended to support more coherent cross‑border enforcement, while leaving some room for Member States and the Commission to shape how extensively and how quickly national measures are mirrored in other jurisdictions.

Osborne Clarke comment

Taken together, the draft amendments point to an incremental recalibration of importer and distributor roles rather than a complete redesign. While the proposal would ease some procedural frictions – for example around repackaging and relabelling – it would also embed a more digital, data‑driven approach to information flows and post‑marketing coordination, including in the context of supply interruptions and other non‑compliances. At this stage, however, the text remains a legislative proposal, and its final contours, timelines and practical impact on supply chain actors will depend on the outcome of the EU legislative process.

Against that background, economic operators may start to reflect on how their existing contractual frameworks, quality systems and digital tools would interact with the envisaged changes, including the reinforced expectations on Union‑wide corrective actions and the developing infrastructure around article 10a. For some businesses, the proposal may mainly confirm directions already taken in response to regulation (EU) 2024/1860, the progressive roll‑out of Eudamed and the broader digitalisation and cyber provisions discussed in parallel initiatives; for others, it may signal areas where future adjustments to internal governance and commercial arrangements could be helpful once the final text is known. In any event, the file is likely to remain a focus for industry engagement in the coming months as institutions and stakeholders work through the detailed balance between regulatory simplification, patient safety, cyber‑resilience and supply chain robustness.