Proposed simplification of MDR and IVDR

[2025-12-16] (Open access) The European Commission adopted on December 17, 2025 a proposal to simplify regulations (EU) 2017/745 for medical devices (MDR) and (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).

Expected like the Messiah by the entire industry (and almost on time for Christmas), this proposal to simplify regulations will now have to be examined by the European Parliament and the Council before being approved and adopted. Please note that some details may change in the meantime, and the timeframe is not specified. However, given the pressure from the various stakeholders, we can hope for rapid implementation.

Since January 7, you can take part in the consultation at the bottom of this page until March 6, 2026, or even later. Indeed, 8 weeks are planned, starting from the complete availability of the documents in all the languages of the European Union. We would also like to draw your attention to the consultation launched by Professor Laurent Castillo, Member of the European Parliament.

Summary of key changes

Relations with notified bodies (NBs)

• NB fees: reduced fees for micro and small companies and for manufacturers of orphan medical devices;
• audits: greater use of remote audits, less frequent surveillance and unannounced audits (surveillance audit every 2 years unless justified, and unannounced audit when necessary);
• dialogue with NBs: setting up a structured dialogue (on a legal basis) between NBs and manufacturers, to make it easier for the latter to obtain answers from NBs less constrained by requirements that prevent them from giving advice;
• special measures for innovative or orphan devices; sandboxes ;
• processing of applications: from now on, NBs will have to process applications and inform the manufacturer within 15 days of receipt. The competent authority may, in the event of a public health or safety issue, oblige a NB to accept an application falling within its scope of designation;
• certificates of conformity : the validity of certificates is no longer limited to 5 years, and NBs will carry out periodic risk-based reviews.
  

Reduced administrative burden

• PRRC: easing of qualification and availability requirements for the person responsible for regulatory compliance;
• reporting and notification: reduction in the number of devices for which the manufacturer must provide a summary of safety and clinical performance, and reduction in the frequency of Periodic Safety Update Reports (PSURs). In addition, longer deadlines are proposed for the notification of serious incidents;
• notification of changes: clearer rules to identify which changes require notification, approval or no action, including the possibility of pre-determined change control plans (as proposed by FDA);
• digitization: more doors open to the digitization (in certain cases) of technical files and operating instructions.

Specific features for some devices

Special features for artificial intelligence

MDR and IVDR are moved from Section A to Section B of Annex I of the AI Regulation. This limits the requirements of the AI Regulation applicable to medical devices, and therefore the risk of overlap.

Special features for medical devices (MD)

• device classification: changes to the classification rules, leading to a reduction in the class of certain devices;
  • the amendment to rule 11 concerning software medical devices was particularly eagerly awaited, and the change is significant since it incorporates terms from IMDRF / SaMD WG/N12 (those familiar with this document will understand) and also since software MDs are now by default in class I and increase in class according to the severity of the clinical situation concerned. Accessories, meanwhile, are classified independently of the device with which they are used;
  • rules 6 and 7: class reduced to I for reusable surgical instruments for short-term or transitory use;
  • article 52.7, reduced application of“class Ir“: reusable surgical instruments complying with harmonized standards or common specifications covering reuse no longer go through a notified body;
• clinical evidence: the possibility of demonstrating safety and performance on the basis of non-clinical data is extended, and the conditions for using clinical data from an equivalent device are relaxed;
• Well Established Technologies (WET): these are devices with a relatively simple, common and stable design, with few evolutions, a well-known safety profile (no significant safety problems in the past), well-established clinical performance characteristics and a long history on the European market. If the device qualifies for this status, then certain requirements may be relaxed, such as an exemption from the implant card requirement, or the possibility of using sampling for the assessment of technical documentation by taking a device representative of a “portfolio” of products.

Special features for in vitro diagnostic medical devices (IVDs)

• sterile Class A devices no longer go through a notified body,
• for Class B and C near-patient diagnostic devices, conformity assessment is based on sampling of technical documentation;
• the text clarifies the composition of kits;
• the requirements are greatly reduced for devices manufactured and used exclusively in healthcare establishments (or in-house tests), which also concern tests used in clinical drug trials;
• for combined drug/device studies, a coordinated procedure is now possible. All that will be required is a single application for authorization under the Regulation on clinical trials on medicinal products for human use (EU) N°536/2014. This latter text is also evolving through the draft regulation to strengthen innovation and competitiveness of biotechnologies in Europe (Biotech Act). Good news for companion diagnostics!

All modifications in a readable format

To analyze all the changes to RDM and RDMDIV brought about by this proposal, you can consult the unofficial working documents (“redline” comparatives) made available by the Commission:

Conclusion

This simplification proposal seems to please the medical industry (see MedTech Europe press release). Several issues that have been highlighted for years have been taken into consideration, without affecting the general safety and performance requirements for devices. The overall thrust of the proposal is towards a more risk-based approach, with levers for manufacturers (especially SMEs) to reduce marketing costs (notably by reducing the administrative burden). In addition, several articles have been revised to avoid duplication and make technical dossiers more coherent.

This proposal, if adopted, is obviously a positive sign for innovation in Europe. It’s hard not to feel that it could have been brought in earlier (a thought for all those SMEs that have been left out in the cold), but let’s not be picky and keep our fingers crossed that the regulations are quickly amended along these lines.

Article written by Karim Chelly, member of DMEXPERTS’ network.