Big News for Medical Device Manufacturers!
The Medicines and Health Regulatory Authority (MHRA) announced on May 21, 2024, that it will start accepting medical devices that already meet regulations in the EU, US, Australia, and Canada. This move aims to streamline the process for manufacturers entering the UK market, saving time and effort. However, this recognition isn’t automatic—manufacturers must meet several conditions for the “certification of international recognition.”
Conditions for UK Recognition
To qualify, manufacturers must:
- Comply with the applicable law where conformity was completed (e.g., EU MDR in the EU).
- Adhere to upcoming UK post-market surveillance (PMS) requirements.
- Ensure labeling is in English.
- Affix a unique device identifier (UDI) and the name of the UK responsible person on the device.
Additionally, they must meet UK standards for electronics compatibility, units of measurement, and materials of concern (CMR). The design, manufacturing process, and intended purpose must align with the device authorized in Australia/EU/Canada/US.
Looking For a Medical Device Regulatory Consultant?
Let’s have a word about your next project
Four Pathways to UK Market Access
The new recognition system offers four pathways:
- Recognition and Self-Registration with MHRA
- For devices like Class I and Class A in the EU, Australia, Canada, and US.
- Reliance
- For devices needing a CE Certificate under EU MDR/IVDR, such as Class IIb and Class C, with matching classifications in the UK.
- Reliance with Device-Specific Requirements
- Applicable to USA Class Is/m/r and Class IIa, IIb, III medical devices.
- Reliance with Abridged Assessment and Device-Specific Requirements
- For devices where classification differs between the UK and other regions, including Class IIa, IIb, III devices complying with Canadian or DeNovo law.
The documentation and review type will depend on the device class and status in the original territory.
Exclusions and Timelines
Some devices, like custom-made devices and certain medical software, will be excluded. The MHRA plans to finalize this recognition approach by 2025 as part of the new UK medical device law. Until then, discussions and testing will define specific elements, like documentation review and post-market surveillance oversight.
UKCA Conformity Path Still Valid
UKCA remains a valid path to the UK market. Even with the new recognition system, the UKCA mark will still be accepted. The MHRA plans to allow a transition period of 3 years for medical devices and 5 years for IVDs for those holding the UKCA mark.
For Expert Guidance on Navigating the New MHRA Recognition System!
Need Compliance Help?
Got questions on medical device and IVD compliance? Contact us today!
References: Statement of policy intent: international recognition of medical devices – GOV.UK (www.gov.uk). Retrieved on 24/05/2024
