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Towards More Predictable Conformity Assessments in the EU: Statement on Annex VII Implementing Act
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Home » Position Papers » Technical Regulatory Affairs » Towards More Predictable Conformity Assessments in the EU: Statement on Annex VII Implementing Act
Technical Regulatory Affairs

Towards More Predictable Conformity Assessments in the EU: Statement on Annex VII Implementing Act

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COCIR welcomes the adoption of Commission Implementing Regulation (EU) 2026/977 (Annex VII on Notified Bodies’ procedures) as a timely and necessary measure towards a more predictable and harmonised EU medical devices system. We appreciate the efforts of EU and national authorities in delivering this important outcome. The act introduces clear timelines and enhanced transparency for conformity assessment activities in Europe.

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