What do we know so far about post-Brexit medical device regulation?
With the new European MDR and IVDR regulations at the forefront of every conversation across the medical device industry, the emerging UK regime may have been overlooked as another pending compliance challenge. Yet, the UK’s exit from the European Union (EU) has brought with it a whole host of new regulatory requirements that manufacturers will need to implement if they wish to continue selling their products on the UK market. The Medicines and Healthcare products Regulatory Agency (MHRA) have issued their delivery plan for the UK’s future regulatory framework and have recently launched their public consultation on the future of medical device regulation in the UK. But what do we know so far about the immediate impact on medical device regulation in the UK?
To help you get started, here are five key takeaways about the emerging UK regulatory system:
1. The UK has entered a transition period
As of the 1st of January 2021, the UK has entered a transition period ending in June 2023. During that period, the UK Medical Devices Regulations (UK MDR) 2002 will remain applicable in England, Scotland and Wales (Great Britain) – while Northern Ireland will follow the EU’s implementation timeline for EU MDR and IVDR. By the start of July 2023, manufacturers will need to have obtained UKCA marking for all their products as the CE mark will cease to be accepted in Great Britain (GB).
2. All products must be registered with the MHRA
Over the course of 2021, manufacturers must register all their products set to reach the UK market with the MHRA. The deadline for registration will depend on the risk-level of the product: high-risk products were to be registered by the 30th of April and moderate-risk devices by the 31st of August, whilst low-risk products have until the 31st of December 2021.
3. Approved Bodies have replaced Notified Bodies
While EU MDR and IVDR conformity assessments for certain device classifications depend on Notified Bodies, the conformity assessment for the UKCA mark relies upon UK Approved Bodies. On the 1st of January 2021, UK-based Notified Bodies became Approved Bodies and were removed from the EU’s list of Notified Bodies. Currently only three organizations are registered to offer this service, with one of those only offering a very limited scope. Device classification rules remain as they were in the three original European Directives for medical devices (MDD, AIMDD, IVDD). Depending on device classification, manufacturers will need to engage with one of the UK Approved Bodies currently listed as early as possible to avoid any demand-induced delays.
From the 1st of January 2021, UK-based Notified Bodies were not recognised in the EU, so non-EU manufacturers must transfer to an EU-27 Notified Body to maintain their CE mark. Likewise, non-EU manufacturers must appoint an EU-based Authorised Representative to continue to access EU markets.
4. UK Representation
Non-UK manufacturers must have a UK-based Responsible Person (UKRP), the equivalent to the EU Authorised Representative. Once a UKRP has been selected – manufacturers can only have one – they will need to set up clear communication channels with them. Manufacturers should look for a UKRP who has considerable regulatory experience with a wide range of medical devices and can guide them through the requirements that apply to their device. The UKRP will then be responsible for registering the manufacturers’ devices with the MHRA, as well as liaising with the MHRA and the device manufacturer on all regulatory actions and investigations.
The conformity assessment processes defined in the UK MDR 2002 (as amended) results in the medical device carrying the UKCA mark (for GB). Alongside the UKCA mark, labels must feature a UK Approved Body number as applicable for the conformity assessment route. Meanwhile, non-UK manufacturers will also need to include their UKRP’s name and registered place of business on their device labelling, next to the UKCA mark. If devices are intended for Northern Ireland but nowhere else in the EU, then the device can bear the UKNI mark instead of the UKCA mark. Businesses would therefore do well to establish how best to plan, resource and schedule the UKCA labelling and Instruction for Use (IFU) transition.
About the author:
Ed Ball is a Senior Consultant at RQM+ and formerly worked as a medical device specialist at the UK Medicines and Healthcare products Regulatory Agency (MHRA), and is currently an active member of the UK’s Technical Committees for Medical Device Quality Management and Risk Management standards. He is an accomplished medical device specialist and chartered engineer, who combines a technical understanding of medical devices with regulatory and quality management experience. Ed has 15+ years of practical experience with a wide breadth of medical devices, including but not limited to EU Class I – III, active devices, implantable devices, diagnostic devices, measuring devices, devices used by lay people, and sterile devices.