Module 17 2024

05/12/2024

Chapter 2: Classification

Active therapeutic medical devices with an integrated or incorporated diagnostic function that significantly determines patient management by the medical device, such as closed loop systems or automated external defibrillators (AEDs), could be classified as Class III.

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Chapter 3: Economic Operators

Essential Requirements/GSPR’s The intention is to broadly reflect the EU MDR GSPRs in the UK regulations but tailored to the domestic context. Further consultation feedback will be taken into consideration by the MHRA in the delivery

of this work. Note: Continue to use ER’s not GSPR’s. Manufacturer obligations – measures for recompense

Manufacturers must have measures in place (for example, sufficient financial coverage to cover legal liabilities) for providing recompense to those impacted by adverse incidents with medical devices on the UK market.

The Organisation for Professionals in Regulatory Affairs

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