[Emergo, UL] Structural Revisions to European Medical Devices Regulation Proposed

You might have heard some rumors already: Several European parliamentarians sent a joint motion for resolution to the European Commission (EC). On October 21st, 2024, a European Parliament resolution “on the urgent need to revise the Medical Devices Regulation” (2024/2849(RSP)) was submitted to the EC.

 

In addition, the Heads of Medicines Agencies (HMA, heads of EU Competent Authorities responsible for the regulation of medicinal products) sent a letter to the Director General for Health and Food Safety (DG SANTE) of the EC expressing their concerns and stating that they “strongly believe that further legislative change must follow appropriate analysis, careful consideration, affirmation of core principles and impact assessment to avoid further unintended consequences.”

 

 

Structural Revisions to European Medical Devices Regulation Proposed | Emergo by UL

Structural Revisions to European Medical Devices Regulation Proposed

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