The Core Problem: Review Burden Without a Clear Link to Risk
A central criticism of the current MDR: Für Produkte, die seit Jahren unverändert und bewährt im Einsatz sind, wächst der Dokumentations- und Prüfaufwand kontinuierlich weiter, unabhängig davon, ob sich am tatsächlichen Risiko etwas geändert hat. Starre Prüfquoten und unangekündigte Audits hit small companies with few products particularly hard: the effort involved is often out of proportion to company size or actual product risk.
A Proposal from the Field: Risk-Based Oversight Instead of Blanket Rules
Ralf Klein, Geschäftsführer der https://radimed.de/en/ und zweiter Sprecher des Regulatory Forums Medizintechnik beim industry association, put forward a concrete solution in an interview with the news platform heise: risk-based oversight instead of uniform requirements for all products. Review resources, he argues, should be targeted specifically where real risks exist. The MDR reform, he adds, must also ensure that established products and medical devices for small patient populations remain commercially viable in Europe – an aspect that comes under regular pressure especially for niche products and small-batch devices.
Looking Across the Atlantic: The FDA's "Grandfathering" Principle
As a point of comparison, Klein points to US approval practice. The FDA allows a form of "grandfathering" for established products that have been safely on the market for decades: these don't need to be completely reassessed. This is exactly the principle, he says, that was missed when the MDR was introduced. Klein puts it bluntly: "The EU MDR, by contrast, requires a complete reassessment for every plastic stopper."
Why the MDR Became So Strict in the First Place
This call for more proportionality doesn't exist in a vacuum – it meets a legal framework that was created for good reason. The MDR replaced older EU directives from the 1990s in 2021, after scandals involving faulty silicone breast implants and metal-on-metal hip replacements showed that products in the EU were often not traceable across borders and that sufficient evidence of safety and efficacy was frequently missing. The current debate, then, isn't about whether strict requirements are fundamentally right, but about how to sensibly balance safety and proportionality for products that carry very different levels of risk.
What This Means for Manufacturers Right Now
One important point to keep in mind: all of this concerns proposals from the European Commission that are currently under discussion not current law. For manufacturers, the MDR in its current form applies in full, without restriction, for the time being. Anyone who waits for possible relief now and neglects their technical documentation or audit management in the meantime is taking an unnecessary risk. It makes more sense to follow the reform's progress closely while continuing to meet existing obligations properly.
How We Support You Through the Current How We Support You Through the Current MDR Phase
Whether the reform ultimately results in noticeable relief remains to be seen. Until then, we're glad to help you meet existing requirements efficiently and without unnecessary extra effort. This includes, among other things:
- creating and maintaining MDR-compliant technical documentation,
- supporting you through audits so they run smoothly,
- continuously monitoring regulatory developments,
- assessing which reforms could become relevant to your product portfolio.
We keep an eye on regulatory developments on your behalf and turn them into concrete, actionable steps for your day-to-day work. Instead of abstract theory, you get clear guidance and pragmatic solutions Feel free to reach out to us – our experts are happy to help.
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