2 min read
Post the Brexit scenario, the Regulatory landscape for medical devices in the United Kingdom (UK) underwent a profound metamorphosis, significantly impacting manufacturers aiming to introduce their products. As the UK made an exit from the European Union (EU), there was a shift from Conformité Européenne (CE) marking to UK Conformity Assessed (UKCA) marking. However, presently, the Medicines and Healthcare products Regulatory Agency (MHRA) still allows the placing of CE-marked devices on the UK market.
The UK is geographically divided into two (02) regions – Great Britain (GB) and Northern Ireland (NI). A key point to be noted here is that the Regulatory strategy for both regions is different from one another. With respect to placing your devices in the GB market, there are two (02) main considerations:
- UKCA Marking: Manufacturers can use the UKCA mark as a new route to market medical devices in GB. This mark indicates that the device in question conforms to the applicable GB regulations.
- CE Marking Extension: The UK government has extended the acceptance of CE-marked devices to June 30, 2030. Devices that comply with the European Union Medical Devices Directive (EU MDD) or the EU Active Implantable Medical Devices Directive (AIMDD) and have a valid CE mark can be placed on the GB market until the certificate expires or until June 30, 2028, whichever is sooner. For In Vitro Diagnostic (IVD) devices compliant with the EU In Vitro Diagnostic Medical Devices Directive (IVDD), the deadline is either the certificate’s expiry date or June 30, 2030.
Key Recommendations for CE-marked Devices
- Understand the Timelines: Get acquainted with the revised timelines for introducing your CE-marked devices into the GB market. The deadline for general medical devices compliant with the EU MDD or EU AIMDD is either the certificate expiry date or June 30, 2028. In the case of IVDs compliant with the EU IVDD, the deadline is either the certificate expiry date or June 30, 2030. Devices compliant with the EU MDR and IVDR must adhere to the deadline of June 30, 2030.
- Register with the MHRA: Ensure that all medical devices, including IVDs, custom-made devices, and systems or procedure packs, undergo the MHRA medical device registration prior to their introduction into the GB market.
- Appoint a UK Responsible Person (UKRP): If you are a manufacturer based outside the UK, appoint a UKRP to act on your behalf for tasks such as device registration with the MHRA.
- Prepare for UKCA Marking: While CE marking is accepted for the time being, prepare for the transition to the UKCA marking system. The UKCA marking has been available since January 01, 2021, and manufacturers can apply to any UK-approved body for the necessary certification. After the transition period is over, the UKCA mark will be required to place devices on the GB market.
- Monitor Transition Guidance: Regularly check for new guidance from 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, onward.
Notably, CE marking for medical devices is still permitted in the UK market. However, the divergence in Regulatory strategies for GB and NI poses challenges. Manufacturers must grasp revised timelines, register devices with the MHRA, appoint a UKRP, and anticipate the shift to UKCA marking. Vigilance on transition guidance is crucial, as the UK government aims to implement key aspects of the future regime by July 01, 2025.
Freyr provides comprehensive Regulatory support to help manufacturers place their medical devices on the UK market. Do you require end-to-end Regulatory support? Schedule a call with us today!
