No-deal Brexit news – registration of medical devices and IVD on the UK market. The situation in the UL can change rapidly however it is still possible that there will be a no-deal Brexit. The regulatory consequences for the medical industry are as follows.
As soon as the Brexit will be a reality, the day, after 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 labeling changes will be required to reflect the role of this ‘UK Responsible Person’.
The Qserve UK office will act as “UK Responsible Person” giving our customers the opportunity to continue selling in one of the key medical device markets in the EU. The office is headed by Sue Spencer who recently joined Qserve. Per September 15th she will be accompanied by Giovanni Di Rienzo. Both are very experienced, in industry and with multiple Notified Bodies. They are eager to support manufacturers to remain to have market access to the UK.
We will continue to feed information to you as the process and the requirements develop.
Please contact us to discuss the ‘UK Responsible Person’ possibilities. The registered business address of Qserve Group UK, Ltd is 49 Greek Street, London, W1D 4EG, United Kingdom.
To contact our local team, please email Sue Spencer at email@example.com.