The Medicines and Health Regulatory Authority (MHRA) has announced on May 21, 2024, the intention to accept medical devices that already conform to regulations in the EU, US, Australia, and Canada and elaborated on its future approach.
This is a positive development for manufacturers who already sell in one of the above markets and should reduce the time and efforts to reach the UK market. Nevertheless, the recognition is not automatic and there are several conditions to be fulfilled in order to reach the “certification of international recognition’’.
Conditions to qualify for recognition in the UK
Manufacturers will need to respect the applicable law in the country, where the conformity has been already completed (for ex. EU MDR in the EU), comply with soon-to-be-adopted UK post-market surveillance (PMS) requirements, have labelling in English language as well as affix unique device identifier (UDI) and name of the UK responsible person on the device.
Moreover, manufacturers will need to comply with the UK requirements for electronics compatibility, units of measurement, and labelling materials of concern where applicable (CMR). Additionally, the design, manufacturing process and intended purpose of the device should be in line with the device that is already authorised in Australia/EU/Canada/US.
Access routes to the UK
The proposed recognition system envisages four pathways to reach the UK market:
- Recognition, self-registration with MHRA.
Some examples are devices that are Class I, Class A in the EU, Australia, Canada, US)
- Reliance.
This would be applicable to devices that need a CE Certificate under EU MDR/IVDR, for ex. Class IIb, Class C, etc. and the classification in the EU does not differ from the UK one.
- Reliance with device-specific requirements
This path is open to USA Class Is/m/r medical devices and Class IIa, IIb, III medical devices.
- Reliance with abridged assessment and device-specific requirements.
Cases, where the classification in the EU, US, Canada, Australia is not aligned with the UK one. It includes Class IIa, IIb, III medical devices that comply with Canadian or DeNovo law, among others.
The needed documentation and type of review will depend on the device class and status in the territory where the manufacturer already reached the conformity.
It is important to note that some devices will be excluded from the future recognition system. This is the case of custom-made devices, software as a medical device not aligned with UK intended purpose, and others.
Timeline
The MHRA intends to set out the final version of the approach towards recognizing devices from several non-UK jurisdictions in 2025. This will form part of the new UK law on medical devices. Until then, several discussions and testing will take place to define certain elements, such as which entity will be reviewing the manufacturer’s documentation, who will oversee the post-market surveillance, etc.
Is UKCA still accepted?
The UKCA remains one of the conformity paths to enter the UK market and at this moment, international recognition is not yet formally accepted. Even once this new approach becomes part of the law, the UKCA will be one of the conformity marks to sell devices in the UK.
The MHRA has also announced that it intends to give sufficient time to manufacturers who obtained the UKCA to transition to the UK new law, i.e., 3 years for medical devices and 5 years for IVDs.
Do you have questions on compliance of medical devices and IVDs? Contact us today.
References:
Statement of policy intent: international recognition of medical devices – GOV.UK (www.gov.uk). Retrieved on 24/05/2024
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