What is happening?
Anyone who believes that everything is "set in stone" with the entry into force of the MDR and IVDR is mistaken. Reality shows that regulations are a living thing. Current proposals from the EU Commission point to significant changes that go far beyond mere formalities.
It's about fundamental issues: How will it be decided in the future whether your product is a medical device or an IVD? What will happen to products that combine both ("integrated products")? And which gaps will finally be closed for accessories for products without a medical purpose (Annex XVI)?
These questions cannot be answered by simply glancing at the law. They require an in-depth examination of the new mechanisms—from the shift of decision-making authority to the member states to the redefinition of the "generic product group."
Know before it becomes law.
To ensure you are not left out in the cold during this dynamic phase, our regulatory experts have launched the Regulatory Update Hub.
In an exclusive video series, we analyze the current proposals for you. We don't just regurgitate legal texts, but translate "officialese" into clear strategies for manufacturers:
- The new demarcation mechanism: Why the EU Commission is relinquishing power and what this means for your "borderline products."
- Integrated products: Why "principal action" suddenly determines your certification strategy.
- Goodbye gray area: Why accessories for Annex XVI products now definitely fall under the MDR.
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