Revision of the MDR and IVDR: European Commission presents reform proposal for simplification

At the latest with the European Commission’s Call for Evidence in September 2025, it became clear that a timely revision of European medical device law was to be expected (see our article). On 16 December 2025, the European Commission presented the long-awaited proposal to amend Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”). 

With its proposal, the European Commission is responding to the structural weaknesses of the regulatory regime that have become increasingly apparent since it entered into force in 2021. Both regulations were originally intended to ensure a high level of safety and health protection while at the same time fostering innovation. In practice, however, the regulations proved to be above all complex and cost-intensive for industry and confronted medical device manufacturers, and in particular SMEs with innovative products, with immense challenges due to limited capacity at notified bodies, conformity assessment procedures that are difficult to plan and rules that inhibit innovation.

The comprehensive reform proposal is now intended to simplify the existing rules while maintaining the high level of safety, to reduce regulatory hurdles for innovative medical devices and to improve the predictability and cost efficiency of the conformity assessment procedure at notified bodies.

I. Simplification of the existing rules

A focus of the Commission’s proposal is on easing the burden on manufacturers, in particular for established medical devices and proven technologies.

• Classification: The classification rules are to be adjusted, as a result of which, in certain cases, medical devices such as reusable surgical instruments, accessories for active implantable medical devices and software will be classified in lower risk classes (Annex VIII MDR).
• Person Responsible for Regulatory Compliance (PRRC): The detailed qualification requirements are to be removed. For SMEs, when using an external PRRC, the PRRC’s availability will be sufficient, rather than a “permanent and continuous” presence (Art. 15 MDR/IVDR).
• Certificates and recertification: The previous maximum validity of five years is to be abolished. Instead of recertification, notified bodies are to conduct risk-appropriate periodic reviews for as long as the certificate remains valid (Art. 56 MDR; Art. 51 IVDR).
• Clinical evidence: The term “clinical data” is to be broadened, the use of clinical data from equivalent medical devices made more flexible and the possibility to base safety and performance exclusively on non-clinical data is to be strengthened (Art. 2 No. 48, Art. 61, Annex II and XIV MDR; Annex XIII IVDR).
• Well-established technologies: A definition for medical devices based on proven technologies (“well-established technology devices”) is to be created. These products are to be subject to simplified rules (Art. 2 No. 72, Art. 18, Art. 32, Art. 52, Art. 61, Art. 86 MDR).
• Repackaging and relabelling: The obligation to notify such activities and to submit a notified body certificate before making the product available on the market is to be eliminated (Art. 16 MDR/IVDR).

II. Reducing barriers for innovation and special products

The Commission's proposal also addresses areas in which the MDR/IVDR have so far been perceived as an obstacle to innovation or as a supply risk.

• In-house devices: The conditions for the manufacture and use of self-developed medical devices in healthcare institutions are to be relaxed. Transfers of in-house devices to other healthcare institutions will be permissible under certain conditions. Under the IVDR, the requirement that no equivalent product is available on the market is to be removed. Central laboratories for clinical investigations are to fall under the exemption (Art. 5(5) MDR/IVDR).
• Conformity assessment for breakthrough devices (BtX) and orphan devices: For new BtX and orphan devices, criteria and facilitations for conformity assessment are to be introduced for the first time. For legacy BtX and orphan devices with CE marking under the directives’ regime, ´grandfathering` is to apply (Art. 52a MDR; Art. 48a IVDR; Art. 120 MDR; Art. 110 IVDR).
• Regulatory sandboxes: To test new technologies, the European Commission and the Member States are to provide regulatory sandboxes (Art. 59b, c MDR; Art. 54b, c IVDR).
• Performance studies: Performance studies involving routine blood draws are to no longer require prior authorization. The notification obligation for studies on companion diagnostics (CDx) using leftover samples is to be eliminated (Art. 58 IVDR).

III. Predictability and cost efficiency of the conformity assessment procedure

The Commission’s proposal is also intended to make the conformity assessment procedure for medical devices, involving notified bodies, more predictable and efficient.

• Structured dialogue and external experts: For the structured dialogues between manufacturers and notified bodies already envisaged in the MDCG guidance, legal bases and clear procedures are to be created. External experts are to be involved for scientific and technical questions (Annex VII MDR/IVDR; Art. 106, 106a MDR; Art. 100 IVDR).
• Conformity assessment: The assessment of the technical documentation is to be limited, for low or medium risk, to representative products to a greater extent than at present. Remote audits are to be possible for notified bodies in justified cases and surveillance audits are generally to take place only every two years (Art. 52 MDR, Annex IX, X, XI MDR; Art. 48 IVDR, Annex IX, X, XI IVDR).
• Remuneration of notified bodies: Reductions in remuneration are to be possible for SMEs and for orphan devices. The European Commission is to be empowered to lay down the level and structure of remuneration (Art. 50 MDR; Art. 46 IVDR).

IV. Other important aspects

• Digital compliance tools: EU declarations of conformity, certain information and instructions for use can be provided electronically, information may be transmitted electronically and digital contact details may be stored in EUDAMED (Art. 19, Art. 52b, Art. 110a MDR, Annex I and VI MDR; Art. 17, Art. 48b, Art. 103a IVDR, Annex I and VI IVDR).
• Removal from the AI Act: Medical devices with artificial intelligence are to be moved in Annex I of the AI Act from Section A to Section B, so that for medical devices, as a rule, only the MDR/IVDR apply, in order to avoid duplicate provisions and overlaps between legal acts.

V. Conclusion and outlook

The Commission’s proposal represents a milestone for the medical devices sector. The European Commission now appears to have recognized that a regulatory system to protect patients and users which is based on highly complex and multi-layered rules reaches a tipping point in implementation if innovative and in some cases life-saving medical devices no longer make it to market in the first place. The fundamental simplification of regulatory requirements and procedures is therefore to be welcomed. However, the original legislative procedure for the MDR/IVDR and the ongoing procedure to reform European pharmaceutical law show how difficult the path to a binding legal act can be. It therefore remains to be seen which of the changes described, or any additional changes, will ultimately make it into the amending regulation to the MDR/IVDR.