With the Brexit commencement, from Jan 1, 2021, there have been a lot of changes in the UK’s medical devices regulations, which the executive Regulatory Authority in the UK – MHRA has devised. Medical device manufacturers willing to enter the UK market especially, England, Scotland and Wales, will have to follow the applicable MHRA UK regulations.
While some changes have come into effect immediately, others have a grace period for compliance. What are those changes, and how are they affecting the medical device landscape in the UK? Let’s decode.
Regulating Medical Devices in the UK Market
Any medical device manufacturer willing to enter both the UK and the Northern Ireland markets must register their devices with the MHRA. It is important to note that different types/Classes of devices are subject to adhere to different Regulatory requirements. Some have a grace period and do not require immediate MHRA registration, while others must be registered immediately. The grace periods for MHRA registration are as follows:
- For Class III medical devices, Class IIb implantables, all active implantable medical devices and List A IVDs, the grace period is four (04) months (until Apr 30, 2021).
- For all other Class IIb medical devices, as well as all Class IIa medical devices and List B and self-test IVDs, the grace period is eight (08) months (until Aug 31, 2021).
- For the subset Class I devices and general IVDs that are not already required to register with the MHRA under the existing rules, the grace period is 12 months (until Dec 31, 2021).
- For Class I devices and general IVDs that are already required to be registered with the MHRA, there will be no grace period.
- Custom-made devices registration will be in line with the risk classification of the device.
A UK responsible person must be appointed for all the manufacturers who are based outside the UK. The UKRP will act on the manufacturer’s behalf to carry out certain activities. The manufacturers in Northern Ireland will also need to appoint an Authorized Representative based in the EU. The UKRP will be responsible for responding to the MHRA queries, providing the requested information and ensuring that the technical documentation is drawn up and the appropriate assessments have been completed. Besides, the UK responsible person plays a critical role in the post-market surveillance of the device. To implement Corrective and Preventive Action (CAPA) that may occur as a result of any complaints or safety issues, the UK responsible person will have to work with the manufacturer and the MHRA. As stated by the MHRA, under post-market surveillance, the manufacturer responsibilities are as follows:
- Once a medical device is placed on the UK market and when certain incidents occur in the UK that involve the manufacturer’s device, they must submit vigilance reports to the MHRA.
- Manufacturers must also take appropriate safety action when required and ensure that their device meets the appropriate standards of safety and performance as long as it is in use.
- The changes in the UK MHRA medical device requirements, specifically for 2023, are planned as follows:
- Until June 30, 2023, CE Marks issued by the EU-based Notified Bodies will continue to be recognized in the UK.
- Until June 30, 2023, the CE Marking certificates issued under current Medical Device Directives (MDD, AIMDD and IVDD) by the Notified Bodies based in European Economic Area (EEA) countries will remain valid.
- The UKCA (UK Conformity Standard) will be compulsory for all devices entering the UK market after June 30, 2023.
- In terms of labeling, all the devices on the UK market must have the UKCA label on them after June 30, 2023. It is not required to re-label the device with a UKCA mark until after June 30, 2023, if the device already has a valid CE marking. A product is acceptable to be labeled with both the UKCA and the CE Mark before and after the mentioned date.
Henceforth, medical device manufacturers willing to enter the UK market must understand and implement the MHRA regulations for a compliant market entry. To gain further comprehensive insights on the MHRA regulations, consult Freyr - a regional Regulatory expert. Stay informed. Stay compliant.