- January 9, 2019
- Posted by: BHTA
- Category: Healthcare News, Industry News
New guidance notes have been issued concerning the Registration of medical devices on the UK market
After 29 March 2019, all medical devices, active implantable medical devices, in vitro diagnostic medical devices (IVDs) and custom-made devices will need to be registered with the MHRA prior to being placed on the UK market.
Given this is an extension of existing registration requirements, there will be a grace period to allow time for compliance with the new registration process as set out below:
|4 months||Class III medical devices, Class IIb implantable medical devices, Active implantable medical devices, IVD List A|
|8 months||Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B, Self-test IVDs|
|12 months||Class I medical devices, Self-certified IVDs, Class A IVDs|
Registration for custom-made devices will be in line with the risk class of the device.
The registration requirements will be as follows:
- initially the MHRA will require most products to be registered at the level of Global Medical Device Nomenclature (GMDN) code meaning that groups of similar products can come under a single registration. The exception is class III devices, which must have individual product information registered
- once the MDR and IVDR fully apply (from May 2020 and May 2022 respectively), the UK will then mirror the new requirements within the legislation, which will mean individual registration of all products
Where a device manufacturer is not established in the UK, registration of a product with the MHRA must be undertaken by a ‘UK Responsible Person’ established in the UK and with a UK registered address who will take responsibility for the product in the UK. No labelling changes will be required to reflect the role of this ‘UK Responsible Person’.
For the full report click here: https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal#medical-devices