Key changes in the MDR revision from the perspective of manufacturers

In December 2025, the European Commission presented a proposal for a comprehensive revision of the Medical Devices Regulation (MDR). Its aim is to reduce the administrative burden, strengthen the proportionality of regulatory requirements, and maintain high level of patient protection. The proposed changes significantly affect medical device manufacturers in particular, covering their products entire life cycle. However, this is a legislative proposal that is now entering the formal debate at the EU level. During the legislative process, Member States and the European Parliament may further amend the text, and its final form may therefore differ significantly from the original proposal.

The revision of the MDR brings changes to the way in which existing obligations of medical device manufacturers are applied and seeks to make regulatory requirements more proportionate. In this context, the concept of "well-established technology devices," i.e., devices based on long-established and clinically well-known technologies, is further clarified. For these devices, a less burdensome approach to conformity assessment is to be applied, including wider use of sampling and limiting the re-examination of parts of the technical documentation that have already been assessed.

Another significant change is the abandonment of the five-year validity period for certificates. Certificates are now to be issued for an indefinite period and their validity will be subject to ongoing supervision based on data from PMS, vigilance, and developments in the state of the art. For manufacturers, this means greater stability and a reduction in administratively burdensome recertifications.

The revision brings greater flexibility in the area of clinical evaluation. It allows for broader use of non-clinical methods, simplifies the demonstration of equivalence, and integrates PMCF results directly into the clinical evaluation report, thereby reducing the documentation burden. Further relief comes from amendments to Article 10 of the MDR, the elimination of duplicate obligations, and the strengthening of the digitization of technical documentation and work with the Eudamed database.

New regulatory tools

In addition to changes to the existing framework, the proposal also introduces new tools and regimes. These include, in particular, the introduction of priority procedures for breakthrough devices and devices for rare diseases, which enable early dialogue with expert panels, ongoing evaluation of documentation and, in justified cases, the marketing of devices based on limited clinical data.

An entirely new element is regulatory sandboxes at national and EU level. These are intended to enable manufacturers of innovative technologies to test new solutions in a controlled environment and with temporarily modified requirements, without compromising safety. The revision also introduces formal procedures for resolving borderline issues and disputes over the classification of devices and strengthens support for small and medium-sized manufacturers, including discounts on notified body fees. Overall, the proposal aims to create a more flexible and predictable regulatory framework.

Author: Markéta Hrubá