Module 17 2024

05/12/2024

Scope of Presentation

The new UKCA will be based primarily on the requirements of the new Medical Device Regulation (MDR 2017/745) now in use in the EU This presentation will concentrate on the main critical areas of the UKCA as well as highlight any major differences between the requirements of the new UKCA and MDR This presentation will only cover the UKCA's medical device requirements (e.g., it will not cover IVD requirements).

The Organisation for Professionals in Regulatory Affairs

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Scope of Presentation

To obtain the best understanding of this presentation a knowledge of the following is required: • An understanding of the MDD 93/42/EEC & AIMD 90/385/EEC (presently the basis for UKCA) • An understanding of existing UKCA requirements, including the transition process • An understanding of the new MDR 2017/745 (the basis for changes to the UKCA)

The Organisation for Professionals in Regulatory Affairs

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