Module 16 2024

23/10/2024

National Laws (UK)

Medical Devices Regulations 2002

Reference to the Annexes to Directives

Can the MHRA impose sanctions for failure to report?

● If device was a Class I device? ● If the device was a Class IIa/b or Class III device? – Sanctions unclear – Consumer Protection Act 1987 – Probably a crime – Breach of a Safety Regulation

The Organisation for Professionals in Regulatory Affairs

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Post-Market Surveillance under the MDR

Manufacturers must implement post-market surveillance system ● Based on post-market surveillance plan

Post-market surveillance report for Class I devices ● Updated when necessary and made available to competent authorities upon request

Periodic safety update reports ● Updated annually for class IIb and III, every 2 years for class IIa ● Submitted to notified bodies for class III and made available to competent authorities ● Others made available to notified bodies and competent authorities upon request

The Organisation for Professionals in Regulatory Affairs

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