Module 17 2024

05/12/2024

Chapter 3: Economic Operators

Health Institutions The new regulations will include a definition of the term ‘health institution’. As a starting point, the definitions set out in the EU MDR, which define a health institution as an organization whose primary purpose is the care or treatment of patients or the promotion of public health, will be used. ‘In-house’ manufactured or modified devices will be required to meet the relevant essential requirements of the UK medical devices regulations; however, there will be exemptions.

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Chapter 3: Economic Operators

Distance Sales No decision has been made at present, the government will have further cross-government discussions to ensure that the approach aligns, where appropriate, with similar measures in place for other products placed on the UK market. Claims The new regulations will include requirements for claims made about medical devices to ensure that any such claims accurately reflect the safety, performance and intended purpose of the medical device. Same as MDR – Article 7

The Organisation for Professionals in Regulatory Affairs

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