The European Commission has recently published an update to the “National requirements for clinical studies” (Version 1.1 – April 2026). This resource is a critical tool for any MedTech manufacturer planning clinical investigations or performance studies under the MDR and IVDR.
Why this matters for your clinical strategy: While the MDR/IVDR provides the harmonised framework, Member States maintain specific national requirements that can impact clinical investigations timelines and documentation. This latest update centralises information provided directly by National Competent Authorities (NCAs), including:
- Direct links to specific national websites for clinical study requirements.
- Updated contact points for NCAs across the Union.
- A dedicated “Extended answers MDR and IVDR” section to address more complex regulatory queries.
If you are planning a multi-country clinical investigation, ensure your strategy aligns with these latest April 2026 updates.
Access the full update here: National requirements for clinical studies.
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