Translated with AI
With the publication of the proposal for a Regulation COM(2025) 1023 final of 16 December 2025, the European Commission has launched the revision process of the MDR (EU) 2017/745 and IVDR (EU) 2017/746 Regulations. These are not marginal amendments, but a significant and long-awaited intervention, designed to address some of the main difficulties that have emerged during the practical application of the regulatory framework, in particular in certification processes and post-market surveillance activities.
The Commission acknowledges the need to make the system more proportionate and sustainable, especially for small and medium-sized enterprises, and to reduce the administrative burden that has affected the sector’s ability to place devices on the market in a timely manner.
Experience from recent years has highlighted complex procedures and significant documentation requirements, which have put pressure on manufacturers and Notified Bodies, with the risk of compromising the availability of essential Medical Devices. The proposal therefore aims to intervene in these aspects by simplifying requirements and processes, without reducing the level of safety provided for by the European regulatory framework.
A new balance between safety and proportionality
The proposal aims to overcome bottlenecks in the certification and post-market surveillance phases, promoting an approach proportionate to the risk, the complexity of the device and the size of the enterprises. In this sense, the reform safeguards the availability of products on the EU market and enhances the role of SMEs, seeking a balance between clinical safety and operational sustainability.
This represents a change of paradigm: the valorisation of clinical experience and post-market data allows for a more sustainable approach, without reducing the protection of public health.
Key points of the simplification proposal
- Certificates with extended validity
The maximum validity period of certificates (currently 5 years) would be removed. Instead of re-certifying devices, Notified Bodies will carry out periodic reviews proportionate to the risk of the device during the validity of the certificate. - Simplification of clinical evaluation for Legacy Devices (Art. 61 MDR)
The proposal reformulates Article 61 MDR by introducing a specific provision for devices placed on the market before the date of application of the Regulation (Legacy Devices) with at least 10 years of robust clinical evidence and a low-risk profile (Art. 1, point 52). For these mature products, clinical evaluation may be based on post-market surveillance and continuous-use data, collected through Real-World Evidence (RWE) and Post-Market Clinical Follow-up (PMCF), reducing the need for additional prospective clinical investigations where the adequacy of the data is demonstrated.
- Innovation and digitalisation
The proposal promotes innovation through Regulatory Sandboxes: controlled environments in which manufacturers can test innovative technologies under the direct supervision of the competent authorities, reducing risks and development timelines.
In addition, the EU declaration of conformity may be issued in digital format. According to future implementing acts, certain information on the label may also be provided digitally. Manufacturers of near-patient tests (decentralised diagnostics) will have the possibility to provide electronic instructions for use (eIFU). All communications required under MDR/IVDR will take place electronically, in connection with EUDAMED.
- Greater flexibility for SMEs and PRRC
The proposal amends Article 15 MDR to clarify that the Person Responsible for Regulatory Compliance (PRRC) does not necessarily need to be employed under a permanent employment contract and may operate on a contractual basis, provided that they fully and continuously perform their functions. In this scenario, external consultants take on renewed importance.
- Reduction of burdens and documentation simplification
The proposal introduces targeted measures to ease the administrative burden without compromising safety.
– Summary of Safety and Clinical Performance (SSCP): the obligation to draw up the SSCP is limited to devices subject to assessment of the technical documentation by a Notified Body. The need for separate validation is also removed, as the draft is already part of the technical documentation.– PSUR: the frequency of Periodic Safety Update Reports is reduced.
– Vigilance: the deadline for reporting serious incidents (not involving death, a serious public health threat or serious deterioration) is extended from 15 to 30 days.
– Performance studies (IVDR): the mandatory notification is removed for studies on Companion Diagnostics that use exclusively residual biological samples (leftover samples).
- Structured dialogue
The proposal introduces a structured dialogue between manufacturers and Notified Bodies prior to the formal submission of the certification application. This preliminary phase is intended to clarify technical and regulatory requirements, reducing the cycles of corrections and requests that currently lengthen approval timelines. More flexible audits are also foreseen, with the possibility of remote audits or a biennial frequency instead of annual audits, calibrated according to the device risk class and the manufacturer’s compliance history.
Next steps
The proposal will now follow the ordinary legislative procedure in the European Parliament and the Council, a process that may still introduce amendments and changes before final adoption. In this transitional phase, it is essential to recall that MDR and IVDR remain fully applicable in their current form.
The winning strategy for companies is not passive waiting, but proactive action allowing them to seize new opportunities.
In this context, the challenge will be twofold: on the one hand, consolidating post-market surveillance processes and clinical follow-up plans to ensure continuity for more mature products; on the other, preparing to take advantage of new acceleration and digitalisation pathways dedicated to more innovative technologies.
Preparing for the transition means being ready for the full operability of the reform expected in the 2027–2028 period, transforming regulatory evolution into a concrete competitive advantage for the safety and sustainability of devices on the market.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2025%3A1023%3AFIN
Publication date: 14/01/2026
