BREXIT IMPACTS ON MEDICAL DEVICE MARKET
Brexit has significantly impacted medical device companies selling in the United Kingdom and European Economic Area (EEA) countries, particularly regarding in-country representation. After the UK left the EU in early 2020, medical device companies face additional certification and in-country representation requirements beyond EU CE Marking in order to market their devices in the UK.
The UK Medicines & Healthcare products Regulatory Agency (MHRA) has indicated that post-Brexit medical device and in-vitro diagnostic (IVD) regulations will align closely with the EU Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). CE-Marked devices will initially be recognized in the UK, but manufacturers will have to obtain UK Conformity Assessment (UKCA) certification starting in July 2023.
How does the new UKCA process affect you?
The two key immediate points of impact for you as a manufacturer are:
- Product registration: the immediate impact to you is to ensure you register your products with the MHRA as soon as possible from 1 January 2021.
- UK Responsible Person: If you are located outside of the UK, you will be required to appoint a UK Responsible Person (UKRP), located in the UK.
- Labelling requirements
- Approved Bodies
PRODUCT REGISTRATION
Manufacturers can voluntarily comply under the new legislation in advance of June 30, 2023, and of course, devices that were never compliant with the European Directives or Regulations would need to be compliant with the new legislation after January 1, 2021.
In addition, on January 1, 2021, there are new MHRA registration requirements for devices placed on the UK market. Before panic ensues, manufacturers should know that the requirements are phased in based on risk class.
The grace periods are as follows:
- 4 months: Class III and Class IIb implantable, active implantable medical devices, IVD List A (until 30 April 2021)
- 8 months: other Class IIb, Class IIa devices, IVD List B, self-testing IVD (until 31 August 2021)
- 12 months: Class I medical devices, general IVDs (until 31 December 2021)
Request Information from our Specialists
Product Registration
Manufacturers can voluntarily comply under the new legislation in advance of June 30, 2023, and of course, devices that were never compliant with the European Directives or Regulations would need to be compliant with the new legislation after January 1, 2021.
UK Responsible Person
Regarding the new registration requirements, manufacturers outside the UK must designate a UK Responsible Person (UK REP). The timeline for this designation is aligned with the grace periods for registration with MHRA, as one of the responsibilities...
Labelling Requirements
If your device is CE certified, you can continue to place your product in the market in the UK until 30 June 2023, there will not be the need to re-label. Similarly, CE Marking certificates issued under current Medical Device Directives (MDD, AIMDD, and IVDD...
How We Help You
UK Responsible Person Services
Submission and Registration Support to the MHRA
Technical Documentation Creation & Updates
Post Market Surveillance
