Update on medical device law - debureaucratisation of the MDR and IVDR

With its proposal to simplify the Medical Device Regulation 2017/745/EU ("MDR") and the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU ("IVDR"), the EU Commission took an important step towards reducing bureaucracy in medical device law on 16 December 2025. The reform proposal is in line with various other initiatives of the EU Commission, such as the proposal for an "EU Biotech Act" or the proposal to amend the "Clinical Trials Regulation", all of which aim to reduce the regulatory burden and costs for manufacturers and at the same time increase the willingness to innovate in the European life sciences sector.

With its reform proposal, the EU Commission is responding in particular to the results of an evaluation of the MDR and IVDR that it commissioned. The evaluation comes to the conclusion that the provisions and procedures of the MDR/IVDR, particularly with regard to the conformity assessment procedure, are too complex, lengthy, time-consuming and cost-intensive. Other points of criticism identified include the lack of uniformity in the application of the law by national authorities on the one hand and notified bodies on the other, as well as inconsistencies with other EU regulations such as the Clinical Trials Regulation or the AI Act. All of these difficulties and uncertainties mean that the European life sciences sector is falling further and further behind the rest of the world in terms of innovation. The reform proposal is now intended to take targeted countermeasures. The industry very much welcomes this, and small and medium-sized companies in particular will benefit from it.

The most important proposed changes include the following:

• PRRC, Art. 15 MDR / IVDR: The high requirement and qualification profile for the so-called "Person Responsible for Regulatory Compliance" as well as the requirement for the permanent availability of the PRRC for small and medium-sized companies is to be abolished.
• Validity of certificates of conformity, Art. 56 MDR / Art. 51 IVDR: The maximum validity of 5 years will be abolished; regular audits by the notified body will replace RE certification of devices.
• Revision of the classification rules, Annex VIII MDR: The risk classification rules are to be amended so that certain products are categorised in a lower risk class. This has the direct consequence of reducing the effort and costs involved in the conformity assessment procedure. These include, for example, reusable surgical instruments and software. In particular, Rule 11 on software classification, which is certainly worthy of criticism, lacks a risk-based approach and effectively categorises all medical software solutions as Class IIa medical devices, is to be amended. In future, medical software solutions that are used for the diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease are to be classified as Class I in the rule. This is a remarkable change of direction.
• Interaction of AI Act and MDR / IVDR: MDR and IVDR are to be transferred from Annex I, Section A to Annex I, Section B of the AI Act. This means that AI-based medical devices benefit from the exemption in Art. 2 para. 2 of the AI Act. This provides that all high-risk AI systems according to Annex I, Section B are largely exempt from the obligations of the AI Act, with the result that the material requirements for high-risk AI systems no longer apply to AI-based medical devices for the most part.
• Vigilance obligations, reporting of serious incidents; Art. 87 MDR / Art. 82 IVDR: In future, manufacturers should have more time to review reported incidents and report them to the authorities. The unrealistic reporting deadline of 15 days, particularly in complex cases, will be extended to 30 days (exception in the case of risks, e.g. to public health and fatalities).
• The reform proposal also includes further changes relating to the reduction of bureaucracy (e.g. simplification of periodic safety reports), the promotion of innovation ("regulatory sandboxes" for innovative products; prioritisation of breakthrough devices and orphan devices) and digitalisation (IFUs, EUDAMED, cybersecurity).

The EU Commission's reform proposals are welcome and speak to the concerns of many manufacturers. If all of these changes are actually implemented, we can expect a greater willingness to innovate and invest in the medical device sector, which will ultimately benefit patients. However, it remains to be seen when and in what form the reform package will actually be implemented.