Medtech Regulatory and Compliance
Key points
- We discuss the European Commission's December 2025 Health Package and its wide-ranging proposals to amend the MDR and IVDR and consider the response from the medical devices sector.
- We look at the AI Act compliance timeline for device manufacturers and highlight updated guidance from the MDCG and Commission on post-market surveillance and supply interruption notifications.
- We also cover the Commission's recent move to permit electronic instructions for use for healthcare professionals, as part of the broader digitalisation agenda.
2025 and early 2026 have been eventful for the medical devices and in vitro diagnostics space at EU level. Against a backdrop of ongoing global uncertainty and continued industry pressure for reform, the period has seen landmark legislative proposals, updated regulatory guidance, and a continued push towards digitalisation.
The standout development is the European Commission’s December 2025 Health Package, which includes a legislative proposal to amend the MDR and IVDR. This reform has been long called for by an industry that has consistently raised the practical difficulties of operating under the current regime. The Proposal is now before the European Parliament and Council and is widely expected to be a key legislative priority in 2026. In this piece, we address the key developments.
The Commission’s Medical Device Regulation / In Vitro Diagnostic Regulation proposal in the December 2025 health package
THE DECEMBER 2025 PROPOSAL
On 16 December 2025, the European Commission published its “Health Package” (the “Proposal”), which included a legislative proposal to amend the Medical Device Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR"). The Proposal has been broadly welcomed by an industry which has long raised the practical challenges of operating under the current regime.
The Proposal addresses a number of structural issues. Classification rules would be revised, with certain device groups, including reusable surgical instruments, some software and active implantable devices, seeing their risk class adjusted downwards, and a new category of “well-established technology devices” introduced for devices with stable designs and a long history on the Union market. The fixed five-year certification cycle for notified body certificates would give way to ongoing, risk-based reviews, reflecting a move towards proportionate, lifecycle-based oversight. Under the Proposal, surveillance audits would be reduced to once every two years, and remote audits, previously only permitted as an exceptional measure during the COVID-19 pandemic, would for the first time be allowed on a routine basis.
The Proposal would allow manufacturers to rely on a wider range of evidence when supporting conformity, including published scientific literature and non‑clinical testing such as bench or computer‑based studies. It would also make it easier to rely on equivalence by removing the need for contractual access to another manufacturer’s technical documentation, allowing use of publicly available information where appropriately justified.
Administrative simplifications include the removal of detailed Person Responsible for Regulatory Compliance (“PRRC”) qualification requirements, a shift from annual to biennial PSUR updates for Class IIb and III manufacturers after the first year, and an extension of the reporting deadline for certain serious incidents from 15 to 30 days.
The Proposal also introduces a new framework for identifying “critical devices”. These devices would be those whose supply disruption could result in serious harm to patients or public health. Under the Proposal the EMA would be tasked with developing and maintaining a list of such devices and manufacturers on the list may ultimately be required to share supply chain risk information in relation to these devices.
In addition, the Proposal establishes a formal EU breakthrough device designation, aimed at accelerating access to highly innovative technologies addressing serious or life‑threatening conditions. Designation would be based on novelty and expected clinical benefit and is intended to create a dedicated pathway enabling earlier and more structured engagement with regulators and prioritisation within conformity assessment, while maintaining existing safety and performance standards. As currently drafted, the Proposal envisages that an expert panel would confirm breakthrough designation based on fulfilment of a number of criteria.
We discuss the Proposal in detail in our briefing: MDR/IVDR: Overview of the Commission’s December 2025 proposed amendments.
ALSO WORTH NOTING: THE AI ACT TIMELINE
The Proposal should be read alongside the Commission's November 2025 Digital Package on Simplification (the “Omnibus Package”). Of particular relevance for device manufacturers, the Omnibus Package proposes extending the compliance deadline for high-risk AI systems under the AI Act. A political agreement on the extension was reached on 7 May 2026. Following adoption of the AI Omnibus regulation in June 2026, the compliance date for high-risk AI systems embedded in products, including most AI-enabled medical devices and IVDs, is 2 August 2028.
For more on AI generally, please see the Data and Digital section.
Industry Response to the Proposal
In March 2026 the European Association of Medical Devices Notified Bodies (“Team-NB”) published a position paper on the Proposal (the “Position Paper”). Team-NB broadly welcomed measures aimed at improving predictability, transparency and efficiency in conformity assessment, and was supportive of the Proposal’s focus on increased digitalisation, enhanced regulatory dialogue and measures to facilitate innovation.
The Position Paper also sounded a note of caution, however, Team-NB emphasised that key elements of the framework, including the European Database on Medical Devices (“EUDAMED”) and the development of Common Specifications, remain incomplete. Team-NB highlighted that any further reforms should be evidence‑based, realistic and implemented in a manner that supports, rather than disrupts, the existing system. In that context, it is worth noting that EUDAMED became mandatory on 26 May 2026. This marked a concrete milestone for manufacturers, irrespective of how the broader reform agenda continues to develop.
The regulation applies to all medical devices used by healthcare professionals, with paper versions remaining available on request.
Updated guidance for manufacturers
GUIDANCE ON POST-MARKET SURVEILLANCE
In 2025, the Medical Device Coordination Group (“MDCG”) published MDCG 2025-10, setting out a common approach for manufacturers and other economic operators on meeting their post-market surveillance (“PMS”) obligations under the MDR and IVDR, with the aim of ensuring consistent and effective implementation across the EU. PMS is a core ongoing obligation under both Regulations, and this guidance provides an authoritative framework for medtech manufacturers in structuring their PMS systems.
UPDATED COMMISSION Q&A: SUPPLY INTERRUPTION NOTIFICATIONS UNDER THE MDR AND IVDR
In April 2026, the European Commission updated its Q&A on Article 10a of the MDR and IVDR, as amended by Regulation (EU) 2024/1860, to include a decision tree providing practical guidance for manufacturers on their supply interruption and discontinuation notification obligations. The decision tree assists in assessing key factors including stock levels, availability of alternatives, and risk to patients or public health, confirming that notification is required where serious harm may arise and must be made at least six months in advance, or without undue delay in exceptional circumstances. This update does not alter the underlying legal requirements but serves as a welcome practical tool for manufacturers navigating obligations which came into force in January 2025.
Commission simplified instructions for use of medical devices
2025 saw the European Commission adopt a regulation allowing healthcare professionals to receive instructions for use (“IFU”) of medical devices in electronic format, rather than solely on paper, in a move that reflects the Commission’s broader ambition to digitalise healthcare systems across the EU. The regulation applies to all medical devices used by healthcare professionals, with paper versions remaining available on request. In addition to supporting the modernisation of healthcare delivery, the regulation aims to reduce environmental impact and ease the financial and administrative burden on device manufacturers - objectives that were broadly supported by professionals and industry representatives in prior consultation. The development marks a further step in the shift towards a more digitalised regulatory environment for medical devices, complementing wider reforms underway under the MDR and IVDR.
CJEU Ruling on Distributor Due Care Obligations
On 4 June 2026, in Case C-10/24 (Dürr Dental), the CJEU clarified that distributors must conduct a "verification of consistency" before making a device available on the market, in line with Article 14 MDR (General Obligations of Distributors). The verification of consistency requires a distributor to check that CE marking, declarations of conformity, instructions for use and other relevant materials clearly relate to an MDR-regulated device. As part of this, distributors are not required to replicate the manufacturer's conformity assessment or independently verify risk class classification, save that where the documents available indicate a device falls within a class requiring notified body involvement (class IIa, IIb or III), distributors must verify that the 4-digit notified body identification number accompanies the CE marking as required by Article 20(5) MDR.
In particular, the ruling has practical significance where products may fall across the boundaries of different regulatory frameworks, and distributors should ensure they are actively reviewing available product materials for any obvious regulatory inconsistencies. Given that Article 14 MDR is unchanged by the Proposal, distributors can expect the CJEU's approach to remain the benchmark for Article 14 due care obligations under the MDR as amended.
What's next?
The legislative progress of the MDR/IVDR Proposal will be the development to watch most closely in the coming months. Now before the European Parliament and Council, it is expected to be a key legislative priority throughout 2026. Industry will be monitoring the trilogue process carefully, in particular whether the more far-reaching simplifications, including the revised classification rules and the eased equivalence conditions, survive the legislative process intact.
Team-NB’s caution that key elements of the framework remain incomplete is a timely reminder that reform and implementation do not always move in step. Against this backdrop, manufacturers should continue to engage closely with the Proposal as it progresses, while ensuring their compliance systems are calibrated to the existing MDR and IVDR obligations in the interim.
For manufacturers of AI-enabled devices, the direction of travel on the AI Act compliance timeline has now been clarified. The political agreement reached on 7 May 2026 confirms that AI systems integrated into regulated products will have until 2 August 2028 to comply, pending formal adoption. This provides greater certainty for product development and go-to-market planning, and manufacturers should factor this confirmed date into their regulatory strategies accordingly.
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