Module 16 2024

10/17/2024

More References

• EUROPEAN COMMISSION – DG SANTE Management of Legacy Devices MDR EUDAMED Ver. 1.2

• BVMed # MDReady Bottleneck Grace Period MDR

• BVMed # MDReady Certificates are not issued on time

• Team-NB-PositionPaper- ExpiringCertificates-20201215

Related Standards and Guidances

• ISO 13485:2016 Medical devices – QM systems - Requirements for regulatory purposes

• ISO 14971:2019 – Risk Management for Medical Devices

• ISO 24971:2020 - Medical Device – Guidance on the Application of ISO 14971

• ISO TR 20416 - Medical devices - Post-market surveillance for manufacturers

The Organisation for Professionals in Regulatory Affairs

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Thank You!

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