Medical device manufacturers selling in the European market will want to take note of the compliance requirements of several new guidance documents.
It has been a busy October month for the European Commission (EC) and for stakeholders participating in the relevant Medical Devices Coordination Groups (MDCG). With the adoption of Regulation (EU) 2024/1860, not only the transitional timelines for IVD manufacturers changed, a new approach on the out role of EUDAMED was announced, but also a new regulatory requirement for both medical device manufacturers as IVD manufacturers was introduced: Article 10a.
EU Update: Several New MDCG Guidance Documents
EU Update: New MDCG Guidance Document 10a
Medical device manufacturers selling in the European market will want to take note of the compliance requirements of several new guidance documents.
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