Module 15 2022

20/05/2022

UK Submission Process – Post Brexit

How to Apply – MHRA, REC & HRA Regulations to be followed Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)

Module 15 Lecture 8

The Organisation for Professionals in Regulatory Affairs

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MHRA submissions:

How to apply 1. Notify the MHRA via e-mail of your intention to conduct the study. 2. Applications must be made via the Integrated Research Application System (IRAS). 3. Complete the MHRA Clinical Investigation Application form on IRAS and upload the relevant supporting documents, submit. 4. The 60 day assessment period will commence once a valid notification is received by the MHRA. 5. All information must be in English.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

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