The medical device industry, one of the most heavily regulated industries, was greatly impacted when the UK withdrew from the European Union in 2016. This has resulted in confusion for medical device manufacturers who must ensure compliance with UK MDR (Medical Device Regulation) and EU MDR.
This blog post aims to explain the critical differences between the UK MDR and the EU MDR and their implications for medical device manufacturers.
The UK MDR vs the EU MDR
The UK Medical Devices Regulation (MDR) contains directives for active implantable medical devices, medical devices, and in vitro diagnostic medical devices (IVDs). The MDR has undergone many amendments since it came into effect in 2002. The primary aim of the MDR is to ensure manufacturers can demonstrate their medical device meets specific requirements to place it on the market in Great Britain. These include general safety and performance requirements, technical documentation and harmonised standards.
The EU Medical Devices Regulation replaces the EU MDD (Medical Devices Directive) as of May 2021. Medical device manufacturers must ensure compliance with the EU MDR to operate within the European market. The MDR replaced the MDD to standardise quality and safety measures for medical devices across all 27 EU member states.
There are several differences between the UK MDR and the EU MDR, including:
- The UKCA (UK Conformity Assessed) mark is required in the UK to demonstrate compliance with UK legislation, while in the EU, the CE (Conformité Européene) mark is required.
- CE marking will be recognised and accepted in the UK until 30th June 2023, and medical device manufacturers will need a UKCA mark on their products.
- If you want to sell your device in Northern Ireland, you must have the UKCA and the CE markings.
- Four approved bodies in the UK can issue UKCA certification, whilst, in Europe, 35 EU-notified bodies can issue CE certification.
What are the implications of these changes in regulatory requirements for medical device manufacturers?
In October last year (2022), the MHRA released a statement saying that they intended to extend the deadline for implementing the new UK MDR. It was initially meant to be implemented on 1st July 2023, but this has now been extended to 1st July 2024. The transitional arrangements for the move to the UKCA mark are up to five years from this date (depending on the type of classification).
As we know, medical device regulations are subject to change, especially given that the EU is also proposing an extension to the transition period for medical and in vitro medical devices for the EU MDR.
If you are a medical device manufacturer looking to place your device on the GB market, the EU market, or both, you need to stay up to date with all of the changes in regulatory requirements. As well as keeping an eye on our blog, where we will do our best to update you, we recommend that you seek advice from us as we offer business consulting services to ensure your medical device complies with the UK MDR and any other relevant regulations.