Simplifying MDR and IVDR

The European regulation of medical devices and in vitro diagnostic medical devices continues to evolve.

On December 16, 2025, the European Commission (EC) presented a Proposal for a "targeted" revision to make the system more agile, predictable and effective, with the explicit aim of strengthening the competitiveness and innovation of the industry while preserving a high level of patient safety.

Background: From the great reform of 2017 to the transitory patches

In 2017, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR) were approved, to modernize a framework that had been in need of updating for two decades. These regulations began to apply in 2021 and 2022 respectively.

The transition, however, was bumpy: certification bottlenecks, disproportionate costs, disparate interpretations and withdrawal or delay of the entry of products into the market, especially affecting SMEs and niche or innovative technologies.

The EU, aware of the difficulties in implementing the new regime, has been expanding the transitional regimes through successive reforms. However, for some years now, a review and simplification of the MDR and IVDR has been in the works.

What does the revision proposal seek?

The Commission's proposal seeks to implement a simpler and more proportionate system, with fewer barriers to innovation and greater coordination between EU Member States. Below we highlight some of the most relevant proposals:

• Extension of the duration of CE certificates. Certificates no longer expire after five years and the idea is that they will become valid indefinitely, with periodic risk-based reviews by the notified body, avoiding unnecessary recertifications.
• Person Responsible for Regulatory Compliance (PRRC). The Commission eases the qualification requirements of the PRRC; in addition, for SMEs that resort to an external PRRC, the requirement of "permanent and continuous" availability disappears; it is enough that it is available.
• Clinical evidence and equivalence. In clinical evidence, the door to equivalence is reopened and the manufacturer will be able to rely on data from an equivalent device in more cases (avoiding having to carry out clinical studies), provided that there is sufficient access to data and the quality and traceability of the original evaluation is clearly demonstrated.
• Risk reduction in classification criteria. Classification rules are adjusted and the class of certain products is lowered (e.g., the door is opened for more software devices to be Class I, so that they can be introduced into the market with self-certification, without requiring a notified body).
• Post-marketing obligations. Reporting of major incidents is extended from 15 to 30 days, and periodic Safety Update Reports are reduced in frequency (e.g., biennial for Classes IIb/III after the first year; IIa according to data-based need).
• Governance of notified bodies. A "structured dialogue" between notified bodies and manufacturers is introduced at the time of pre- and post-presentation, and more risk-based audits are regulated (with more use of remote audits, less frequent surveillance if applicable, and only "unannounced" inspections for cause, among others).
• Adaptive pathways for "innovative" and "orphan" medical devices. After appointment by an expert panel, they will enjoy priority, early advice and the possibility of certifying with limited pre-commercial data when the benefit-risk balance is favourable, with enhanced post-market monitoring. In addition, certain "orphan" medical devices with CE marking under the old Directives could remain on the market beyond the transitional periods, subject to certain conditions.
• Regulatory sandbox. Controlled environments to test in practice requirements applicable to innovative technologies (highly relevant to software/AI), without suspending substantive MDR/IVDR obligations and under clear criteria of eligibility, safeguards and supervision.
• In-house devices of health institutions and laboratories. Conditions are relaxed, in particular less documentary burden and the possibility of transfers between institutions for public health or patient reasons.
• Digitalization. with emphasis on EU declarations of conformity in digital format, extended eIFU (for near-patient tests) and the obligation to process electronically in MDR/IVDR.
• Borderline products. The "Helsinki Procedure" is codified for border and classification decisions, with coordination obligations between Member States, the possibility of requesting opinions from panels of experts and target deadlines. For disputes with notified bodies, an expedited channel is established before the national competent authority.

Calendar and status of the procedure

• 16 December 2025. Commission publication of the proposal.
• 7 January – 19 March 2026. Public feedback period for legislative debate (opened by the Commission).
• 2026 onwards. Parliament-Council negotiation and adoption of the final text; The date of entry into force will depend on the outcome of those negotiations.
  

This revision aims to turn a framework perceived as complex and expensive into a predictable, digital and proportional one, which accelerates access to secure technology without penalizing those who innovate. If adopted in the terms proposed, the "new MDR/IVDR" will be easier to navigate for actors operating in the health technology sector.

For more information, please contact our specialists through the Knowledge and Innovation Area.