Module 17 2024

05/12/2024

Chapter 4: Registration and UDI

Economic operators will have up to a 30-day timeframe to update an MHRA registration record after a change has been made to registration details. They will also have to confirm all data submitted in their device registration one year after submission and then every second year thereafter. The regulations will require the identification of certain economic operators (such as manufacturers (including assemblers or sterilizers of system or procedure packs), UK Responsible Persons, importers and distributors of a medical device to register with the MHRA. When registering, the economic operators will be issued with a unique MHRA generated number. In addition, if it is already held, an economic operator will be able to voluntarily provide another internationally recognized external reference (for example, DUNS, GLN, SRN).

The Organisation for Professionals in Regulatory Affairs

35

35

Chapter 5: Approved Bodies

The following additional requirements will be placed on Approved Bodies: a. Organisational structure: The Approved Body will document its organisational structure and the functions, responsibilities, and authority of its top-level management b. Independence and impartiality: The Approved Body will document and implement a structure and procedures for safeguarding impartiality. Such procedures shall provide for the identification, investigation, and resolution of any case in which a conflict of interest may arise, including involvement in consultancy services in the field of devices prior to taking up employment with the notified body. The investigation, outcome and resolution shall be documented

The Organisation for Professionals in Regulatory Affairs

36

36

18