Januar 21, 2021
UK Conformity Assessed
Roadmap to Brexit: Compulsory Registration and New Marking Requirements
CE labelling is no longer accepted for medical products in the UK, except for a short grace period. The UK has introduced its own marking system.
Since 1 January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Great Britain market need to be registered with the MHRA. There is a grace period for registering:
• Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered from 1 May 2021
• other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 1 September 2021
• Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from 1 January 2022
UK Responsible Person
The registration is to be conducted by a so-called UK Responsible Person. Manufacturers based outside the UK are required to appoint a UK Responsible Person that is established in the UK. Importers and distributors are not required to appoint a UK Responsible Person.
UK Conformity Assessed
The UK has introduced a new marking system for certain goods, including medical devices, which is only valid for the Great Britain market and is not accepted by the EU, EEA or Northern Ireland.
The mandatory usage of the UKCA mark (UK Conformity Assessed) for medical devices placed on the UK market comes into effect on 1 July 2023.
The UKCA mark requirements for medical devices are based on the three main types of medical devices and their associated part in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002):
• general medical devices: Part II of the UK MDR 2002
• active implantable medical devices: Part III of the UK MDR 2002
• in vitro diagnostic medical devices (IVDs): Part IV of the UK MDR 2002
Class I devicse and general IVD manufacturers can self-certify against the UKCA mark. Where third party conformity assessment is required, a UK approved notified body is needed.
UK Approved Bodies
UK approved bodies are designated by the MHRA.
Existing UK notified bodies with designations under the EU MDD, EU IVDD or EU AIMDD have had their designations rolled over automatically, without having to undergo a new designation process.
The UK government has set up a new domestic database, UK Market Conformity Assessment Bodies, to replace the EU’s NANDO information system.
Regulation of Medical Devices in Northern Ireland
Under the terms of the Northern Ireland Protocol, the rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain (England, Wales and Scotland).
There is a requirement, in most cases, to register devices with the MHRA and have a UK Responsible Person if the manufacturer is based outside the UK, as set out below.
Complete Guidance: Regulating Medical Devices After Brexit
Source: www.gov.uk © MTME 2021