Recent Developments Within the Scope of the MDR
The first part of this article focuses on the simplifications proposed by the European Commission in its proposal of 16 December 2025.
Why are we only reporting on this now? Because the changes proposed at the time are still exactly that: proposals. The proposals are still going through the legislative process. In the meantime, however, key conditions have been put in place, so attention is now turning once again to the next regulatory steps.
But now things seem to be moving forward – the four core EUDAMED modules are operational and mandatory. This enables the European working groups to press ahead with further reform plans.
Simplifications in the MDR
The European Commission’s proposal is a comprehensive revision of various sections of the MDR. We have summarised those that will be particularly relevant to manufacturers of medical devices in Classes I, IIa and IIb should the Commission ultimately implement them.
- Certificates of conformity with indefinite validity: Certificates of conformity issued by notified bodies are no longer to be limited to five years, but are to be valid indefinitely as a matter of principle. This is subject to regular inspections by the notified body, which are to become standard practice in future.
- Limited SSC obligation: Under the proposed amendments to Article 52 of the MDR, the obligation to draw up and regularly update a Summary of Safety and Clinical Performance (SSCP) for certain medical devices, in particular so-called ‘well-established technologies’, is to be restricted. In future, an SSCP will only be required for products for which a technical documentation review by the Notified Body is envisaged.
- Person Responsible for Regulatory Compliance with simplified requirements: Article 15 of the MDR sets out the requirements for the Person Responsible for Regulatory Compliance (PRRC)
These are to be simplified; in particular, small and medium-sized enterprises will no longer be required to maintain a PRRC that is available at all times. It is not yet clear exactly how the role of the PRRC will be defined in future – however, in our view, it is rather unlikely that the role will be abolished entirely. - Digitalisation planned: Most processes can already be carried out entirely without paper. There are plans to expand digital procedures – for example, for the transmission of documents to and from Notified Bodies, the provision of product information (as is already the case via EUDAMED) and greater use of digital instructions for use.
Nothing’s Settled Yet
These amendments have not yet been finalised. They are therefore proposals put forward by the legislature, intended to prepare the sector for forthcoming changes and to set the direction for the future.
When observing democratic negotiation processes such as this one, one thing is clear: the content can still change significantly before the final adoption. That is part of the European legislative process.
Many of the proposals listed here are also likely to change during the negotiation process – headlines such as ‘End of the PRRC requirement’ therefore often provide only a simplified account of the current situation.
However, we believe that the trends set out in the Commission’s proposal are likely to prevail to a large extent. Manufacturers can therefore expect simplified conformity assessment procedures, more digitised regulatory processes and a noticeable reduction in red tape.
BEO BERLIN at Your Side
As an advocate for small and medium-sized medical device manufacturers, BEO BERLIN has been guiding its partners through the regulatory jungle since the turn of the millennium.
We continuously monitor legislative developments, assess changes and support our partners in finding suitable solutions for their products.
Our experts are not afraid of any challenge and keep up with the latest developments to ensure that your products are successfully launched on the market and included in the medical devices register.
Do you have any questions about the latest MDR developments, or would you like to know how the planned changes will affect your business? Please get in touch – we’d be happy to advise you.
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