UKCA Compliance: Medical device manufacturers have been under pressure for a while now, trying to ensure they are compliant with the EU Medical Device Regulation (MDR) and the upcoming In Vitro Diagnostic Regulation (IVDR). That pressure is not about to ease up as the UK’s exit from the European Union (EU) has introduced a new set of regulatory requirements.
The UK will continue with the UK Medical Devices Regulations 2002 (S.I. 2002/618) (UK MDR), as amended, and by the 30th of June 2023, manufacturers will need to follow the UK Conformity Assessment process and place the UKCA mark on their medical devices, as CE marked medical devices will stop being recognised in Great Britain (England, Scotland and Wales). CE marked devices will continue to be accepted in Northern Ireland, as the EU MDR and IVDR will apply from their respective dates of application.
The conformity assessment processes defined in the UK MDR 2002 (as amended) results in the medical device carrying the UKCA mark (for GB) or UKNI mark (for NI). 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. In addition to this, all medical devices on the UK market must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA).
With so many efforts placed first on achieving EU and now UK compliance, it is critical that businesses identify and seriously evaluate any potential overlap in the preparation towards these different regulations to ensure they remain efficient. This understanding will eliminate duplication of effort, help identify gaps in data and documentation and can even drive medical device manufacturers to set their strategy for the coming years as well as make product portfolio decisions regarding the UK and EU markets.
Depending on various factors (how far along the EU MDR or IVDR compliance process was, the classification of the product and more), businesses will need to funnel more resources and investment in complying with UK regulation. Taking stock of the compliance progress made to date and comparing requirements will help achieve efficiency and faster times to market. Based on compliance risk, classification, CE mark status, UK regional sales and level of preparedness, manufacturers will be able to make effective decisions on whether or not to pursue the UKCA mark for all the product categories they currently supply to Great Britain and Northern Ireland.
One of the most anticipated risks is that posed by time; as of the 1st of January 2021, the UK conformity assessment for certain device classifications will depend on UK Approved Bodies, rather than the EU Notified Bodies. There are currently only three UK Approved Bodies to manage all the demand, so a bottleneck looms large. Savvy businesses should engage with a UK Approved Body early to ensure they are able to get their UKCA mark in time. Alternatively, those manufacturers who use EU Notified Bodies with no formal presence in the UK currently should open the dialogue with their Notified Body to determine their intentions. If they plan to establish themselves as a UK Approved Body, then it may be prudent to wait for their entry and maintain the relationship with the same organisation rather than using different certification bodies for the EU and the UK.
The key to not becoming overwhelmed by this new onus is planning ahead. Making the most of the ‘standstill’ or transition period, ahead of the 2023 deadline, could help ensure that manufacturers hit the ground running. At the same time, it is important not to rush the task without strategy and to take advantage, for example, of the different deadlines for registering devices with the MHRA depending on their classification. High risk devices needed to be registered by 30th April 2021, moderate risk devices by 31st August 2021 and low risk devices by 31st December 2021.
Another area where non-UK manufacturers would do well to move in early is the appointment of a UK Responsible Person (UKRP). Roughly equivalent to the EU Authorised Representative, the UKRP will need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). Their name and registered place of business will appear on the device labelling, next to the UKCA mark. Non-UK manufacturers should have had a UKRP in place as of 1st January 2021 and must have a UKRP in place at the time of registering their devices with the MHRA.
Businesses will need to invest time and resources in ensuring they remain up to speed on numerous changes such as newly listed UK Approved Bodies, implementation of policy advice from the Cumberlege Review, potential fast-track conformity assessments for CE-marked devices, liability insurance issues, the publication of new versions of standards listed as designated standards, labelling, documentation and data exchange protocols, as well as any emerging UK-EU equivalency.
Updated guidance on conducting clinical trials, especially across multiple sites in different countries, is also likely to evolve during the transition. Manufacturers carrying out clinical trials in the UK will need to review guidance on topics such as submitting safety reports, making substantial amendments to clinical trials, and new MHRA guidance.
Similarly, the treatment of patient data is another area that is in flux. As more and more ‘sensitive’ information needs to move between the UK and the EU, UK data protection rules and GDPR will need to be monitored closely. Staying abreast of new developments by following information from the relevant authorities will need to be added to the new onus of administrative tasks such as import and export administration.
Special attention needs to be paid to documentation and flows of information with new partners and parties; in particular, once the process of sourcing a UKRP has been addressed it is important to understand how to manage certification and documentation with them as part of establishing the relevant agreements with that UKRP. Similarly, businesses would do well to establish how best to plan, resource and schedule the UKCA labelling and Instruction for Use (IFU) transition as well as understanding how to deal with import/export controls and documentation rapidly and cost-effectively.
We are presented with a highly dynamic and fragmented regulatory landscape that is set to develop further throughout the ‘standstill’ or transition period. While UK regulations have provided a valuable opportunity to address concerns relating to medical device safety, as indicated in the Cumberlege review, significant challenges lie ahead. Starting with the plans to appoint a Patient Safety Commissioner (PSC) as recommended by the review, through to new guidance documents expected from the MHRA, there is an unprecedented opportunity to review product portfolios, thus improving patient safety but also competitive advantage.
Ed Ball, Senior Associate at RQM+
Ed Ball 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.
