Module 17 2024

05/12/2024

Chapter 5: Approved Bodies

Legal entity Approved Bodies will require a distinct legal entity based in the UK; therefore, a branch of an EU Notified Body will not be sufficient unless this branch is a distinct legal entity in its own right. Approved Bodies designation and monitoring • Approved Bodies applying for designation must hold appropriate UKAS accreditation. • New requirements for MHRA assessment of Approved Bodies to be implemented Fees The proposal to “Make their fees available on request to any interested party” has not been accepted and won’t be included in the new regulations. However, this will be replaced by the following in the regulations: “ To require that an Approved Body make their fees available on request by the Secretary of State”.

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Chapter 6: Conformity Assessment

The regulations remove the option to use type examination for all medical devices (Annex X MDR). As a consequence, for production quality assurance (Annex XI Part A), this route will also be removed for class III and class IIb devices Improve the scrutiny placed on implantable medical devices. All Class IIb implantable devices (except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) will be subject to 100% review of their technical documentation as opposed to a representative review by Approved Bodies. Require that reusable surgical instruments undergo review by an Approved Body with respect to aspects relating to the reusability of the device, such as sterilisation and functional testing

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