Module 17 2024

05/12/2024

Chapter 9: IVD’s

This chapter is not covered in this presentation.

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Chapter 10: Software as a Medical Device

Scope and definitions Clarification of the meaning and scope of the term ‘Software’, by adding a new definition of Software to the UK medical device regulations. The definition is " a set of instructions that processes input data and creates output data.” This definition is consistent with the one in the EU’s MEDDEV 2.1/6. Distance sales The government will explore this area further, the scope to proceed with any possible changes and will have further cross-government discussions to ensure our approach aligns, where appropriate, with similar measures in place for other products placed on the UK market

The Organisation for Professionals in Regulatory Affairs

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