UK MHRA issues post-Brexit medical device, IVD registration requirements

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on registration requirements and deadlines for medical devices and IVDs effective January 1, 2021 for some products.

According to the new MHRA guidance, the January 1, 2021 registration deadlines pertain to manufacturers of Class I medical devices, IVDs and custom-made devices and that are either based in the UK or whose Authorized Representatives are based in Northern Ireland. UK regulators have scheduled grace periods for other device types based on their risk classifications.

As previously reported by Emergo by UL, the MHRA will continue to recognize European CE Marking as well as compliance to European Medical Device Directives, the Medical Devices Regulation (MDR) and  the In-vitro Diagnostic Medical Devices Regulation (IVDR) through June 2023. From that point on, manufacturers will need to obtain UK Conformity Assessed marks, or UKCAs, to be legally marketed in England, Scotland and Wales. In Northern Ireland, separate requirements regarding CE Marking as well as UKNI marking will apply.

Grace periods and deadlines for MHRA registration

The MHRA has set the following deadlines for registration:

• May 1, 2021: active implantable medical devices, Class III medical devices, Class IIb implantable medical devices and IVD List A devices
• September 1, 2021: Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B devices, self-test IVD products
• January 1, 2022: Class I medical devices and general IVDs from manufacturers or Authorized Representatives are not based in the UK

What to include in MHRA registrations

On or before their applicable registration deadlines, device manufacturers must submit company, device and UK Responsible Person (UKRP) information to MHRA via the regulator’s Device Online Registration System (MHRA DORS); companies must set up MHRA DORS accounts before entering registration data into the online system.

The new MHRA guidance also includes examples of registration information required for custom-made devices as well as system and procedure packs.

Manufacturers should be aware that the MHRA will only accept device registrations from companies or UK Responsible Persons established in the UK, or from Authorized Representatives based in Northern Ireland.

Related UK and European Union medical device and IVD regulatory resources:

• UKRP and Brexit transition consulting for medical device and IVD companies
• EU Medical Devices Regulation (MDR) preparation and compliance resource center

Related services for Europe:

• CE Mark Certification for Medical Devices
• Clinical Evaluation Reports (CER) for Medical Devices in Europe
• EU IVDR Gap Assessment and CE Transition for IVD Companies
• EU MDR compliance consulting for cosmetic and aesthetic products
• EU Medical Device Vigilance Reporting in Europe
• EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
• European Authorized Representative for Clinical Trials
• European Authorized Representative for Medical Device Companies
• European MDR 2017/745 Gap Assessment and CE Transition Strategy
• European Union Medical Device Classification
• In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
• IVD Certification and Registration to Obtain CE Marking in Europe
• Medical Device and IVD Emergency Use Routes in Europe
• Medical Device Technical File and Design Dossier for EU CE Marking
• Switzerland Representative for Medical Device Companies
• UKRP and Brexit consulting for medical device companies