European Commission presents legislative proposal for simplification.

As part of the EU Health Package presented on 16 December, the European Commission published a legislative proposal to simplify Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The aim is to simplify certification procedures, reduce administrative burden and accelerate market access for medical devices and in vitro diagnostic medical devices. According to the Commission, the regulatory framework is to be streamlined and made future-proof. Predictability, cost-efficiency and efficiency of certification procedures are to be improved, barriers to innovation reduced and the availability of medical devices ensured.

Simplification and proportionality

A central element of the proposal is a reorientation of the certification logic. The current five-year validity limit for certificates is to be abolished; instead, state-designated and supervised organisations responsible for certification (so-called Notified Bodies) are to carry out regular, risk-based assessments throughout the certificate’s lifetime. In addition, requirements for clinical data are to be made more flexible. In the future, expanded datasets are to be recognised as clinical data and reliance on data from an equivalent device will be facilitated. For so-called “well-established technology devices”, a separate definition with more proportionate requirements is to be introduced for the first time. Risk classification is also to be adjusted: certain products – such as reusable surgical instruments, accessories for implantable medical devices or software – are to be assigned to lower risk classes in the future.

Innovation, availability and specific care situations

To safeguard innovation and continuity of care, the rules for in-house devices in healthcare institutions are to be made more flexible. At the same time, a new IT tool linked to EUDAMED is to be introduced, allowing the reporting of supply interruptions or discontinuations of specific medical devices. In addition, criteria for “breakthrough devices” and “orphan devices” are to be introduced for the first time. Following designation, these products are to be prioritised and subject to continuous review. Under certain conditions, orphan devices may also be allowed to remain on the market beyond existing transitional periods. Furthermore, in the event of a public health emergency, the Commission is to be granted the power to authorise the placing on the market of medical devices itself.

Certification, coordination and digitalisation

The role of Notified Bodies is to be reduced in particular for low- and medium-risk products. Among other measures, technical documentation is to be assessed only for a representative product per product group; for sterile class A in vitro diagnostics, the involvement of Notified Bodies is to be eliminated entirely. Audit and consultation procedures are to be designed more flexibly, for example through increased use of remote audits. Another key focus is digitalisation: EU declarations of conformity, labelling information, instructions for use and technical documentation are to be made available in digital form.

Alignment with the Artificial Intelligence Act

The proposal also provides for an amendment to the AI Act, even though this legislation is already being revised under a separate omnibus procedure. Specifically, the MDR and the IVDR are to be moved from Section A to Section B of Annex I of the AI Act. The products and safety components covered by these acts would therefore in future be subject to a less stringent set of requirements for high-risk systems.

More than a targeted adjustment

The announced “lean and targeted” adjustment of the MDR and IVDR proves, at around 170 pages, to be significantly more extensive than originally indicated and in some respects amounts to a recalibration of the existing regulatory approach. The proposal includes politically far-reaching elements such as expanded intervention powers for the Commission in crisis situations, additional IT structures for shortage reporting via EUDAMED despite its currently limited functionality, and amendments to the AI Act with lowered requirements for MDR and IVDR products in the high-risk category. It therefore cannot be described as a merely “minor” or technical reform.

From the DSV’s perspective, targeted legislative fine-tuning can be appropriate, provided it genuinely reduces administrative burdens and facilitates access to medical devices and in vitro diagnostics without compromising patient safety or the quality of clinical data. This will need to be carefully examined in detail.

Outlook

The legislative proposal will now be discussed in the Council and the European Parliament. The Cypriot Council Presidency has announced that it will treat the MDR/IVDR adjustment as a priority. The conclusion of the legislative process appears possible before the summer recess of 2026.