Post the Brexit scenario, the Regulatory landscape for medical devices underwent a profound metamorphosis, impacting manufacturers who were aiming to introduce their products into the United Kingdom (UK) market. As the UK exited from the European Union (EU), there was a shift from Conformité Européenne (CE) marking to UK Conformity Assessed (UKCA) marking. However, currently, the Medicines and Healthcare Products Regulatory Agency (MHRA) still allows for the placing of CE marked devices on the UK market.

Geographically, the UK has been divided into two (02) regions – Great Britain (GB) and Northern Ireland (NI). A key point to note here is that the Regulatory strategies adopted for both geographies are different from each other. With respect to the GB market, there are two (02) primary approaches that can be followed, as mentioned below:

• UKCA Marking: Manufacturers can use the UKCA marking as a new route for marketing their medical devices in GB. This marking indicates that the device conforms to the applicable GB regulations.
• CE Marking Extension: GB has extended the date for the acceptance of CE marked devices. Devices that comply with the EU Medical Devices Directive (MDD) or the EU Active Implantable Medical Devices Directive (AIMDD) with a valid CE marking can be placed on the GB market until the certificate expires or until June 30, 2028, whichever date is sooner. For In Vitro Diagnostic (IVDs) medical devices that are compliant with the EU In Vitro Diagnostic Medical Devices Directive (IVDD), the deadline is the certificate’s expiry date or June 30, 2030, depending on whichever date is sooner.

Key Considerations and Recommended Measures for CE Marked Devices

Here are the key aspects manufacturers need to consider with respect to CE marked devices:

• Understand the Timelines: Manufacturers should acquaint themselves with the revised timelines for introducing CE marked devices into the GB market. As mentioned earlier, the deadline for general medical devices compliant with the EU MDD or EU AIMDD is the certificate’s expiration date or June 30, 2028, whichever date is sooner. In the case of IVDs compliant with the EU IVDD, the deadline is the certificate’s expiration date or June 30, 2030, whichever comes sooner. Moreover, devices compliant with the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) must adhere to the deadline of June 30, 2030.
• Register with the MHRA: Manufacturers must ensure that all medical devices, including IVDs, custom-made devices, and systems and procedure packs, undergo the MHRA medical device registration prior to their introduction into the GB market.
• Appoint a UK Responsible Person (UKRP): Manufacturers based outside the UK have to appoint a single UKRP to act on their behalf for tasks such as carrying out device registration with the MHRA.
• Prepare for UKCA Marking: While CE marking is accepted for the time being, manufacturers need to prepare for the transition to the UKCA marking UKCA marking has been made available since January 01, 2021, and manufacturers can apply to any UK-approved body to get the necessary certification for their medical devices. After the transition period is over, the UKCA mark will be mandatory to place devices on the GB market.
• Monitor Transition Guidance: Manufacturers should check for new guidance documents released by the UK government and the MHRA regarding the future regime for medical devices, as the government is aiming for core aspects of the future regime to be applicable from July 01, 2025.

Notably, CE marked devices are still permitted in the UK market. However, divergences in the Regulatory strategies of GB pose significant challenges. Manufacturers must be able to grasp revised timelines, register devices with the MHRA, appoint a UKRP, and anticipate the shift to UKCA marking. In fact, to restate, conducting proper vigilance on transition guidance is crucial, as the UK government aims to implement key aspects of the future regime by July 01, 2025.

Is your medical device ready for the transition to the UKCA marking system? Are you on the lookout for expert Regulatory assistance? Reach out to us now!