January 1, 2021, ushered in significant change for the UK but also for medical device manufacturers worldwide wishing to continue to sell their products in this market. Although it is merely the start of a transition period toward a new regulatory regime, businesses would do well to take note of a series of deadlines and dates, culminating with the June 30, 2023, the date by which their devices must have obtained UKCA marking to continue to be present in this market. In addition to working toward achieving compliance for the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device businesses with products on the UK market will need to plan ahead to ensure that they achieve UK compliance in time.
The UK’s exit from the European Union (EU) has also created a divergence between the requirements for Great Britain (England, Scotland, and Wales) and Northern Ireland. The ongoing pressures and increase in compliance requirements in the UK and EU markets are putting a strain on medical device manufacturers and regulatory authorities alike, but there may well be some overlap that businesses would do well to identify and leverage to their advantage throughout the transition phase.
Filling in the Gaps
Medical device manufacturers are no strangers to managing regulatory changes; for the past few years, companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR).
With the UK exiting the EU, however, manufacturers wishing to remain in the UK market will need to comply with the UK Medical Devices Regulations (UK MDR) 2002 as amended and for access to the Northern Irish market, the EU MDR and IVDR. The UK MDR 2002 is based on the three outgoing EU directives for medical devices and in vitro diagnostic medical devices, but it is likely that future UK legislation will come to closely resemble the EU MDR and IVDR.
It follows that manufacturers wishing to make the most of their efforts so far and avoid any duplication of activity should thoroughly assess any gaps in data and documentation and plan strategically around these, ensuring they repurpose efforts and resources invested into complying with EU MDR and IVDR for UKCA marking wherever possible.
Taking a Product-by-Product Approach
Every time a product is taken through compliance assessments, it’s critical to make a firm evaluation of how valuable the product is within the specific market and to set this against the cost of achieving compliance to keep it there. Manufacturers are advised to assess the compliance risk of products based on device classification, CE mark status, UK regional sales, and level of preparedness. On this solid basis, manufacturers must consider whether it makes commercial sense to continue to supply all product classes to the UK or not. This approach may also reveal that introducing new products to the UK market is more cost-effective than previously thought, making the exercise worthwhile for most manufacturers.
Building a Network of Partners
A new regulatory framework also requires a new set of actors and responsible parties. Instead of an EU Authorized Representative, for example, non-UK manufacturers must have a UK-based Responsible Person (UKRP) with a registered place of business in the UK to continue trading in the UK. One of the key responsibilities of the UKRP is to complete device registration with the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the device manufacturer. The name of the UKRP will also need to be included on future labeling or IFU alongside the UKCA mark.
Another key player in this environment will be the UK Approved Body. To date, conformity assessments have been carried out by EU Notified Bodies, but they will not be able to provide UKCA marks. UK organizations that were previously acting as Notified Bodies are now automatically UK Approved Bodies, but unfortunately their numbers are limited and stand at three. It is evident that there is a very real risk of these few UK Approved Bodies rapidly becoming overburdened with high demand for their services, so manufacturers would do well to engage with one early to ensure they are not held up by a bottleneck.
Staying One Step Ahead
EU-based manufacturers and UK importers are likely to see an uptick in administrative tasks relating to importing and exporting medical devices along with associated costs. Most importantly of all, however, they will need to manage their internal resources efficiently. Further practical issues within the supply chain may emerge after June 2023 once the CE mark is no longer recognized, making it vital that all parties are clear on the implications of any new procedures and controls. Close contact with the relevant regulatory authorities will help businesses stay ahead of the emerging situation and of the competition.
As the deadline for UKCA marking draws near and more and more businesses start submitting their UKCA documentation, common pitfalls are likely to begin to emerge. At the same time, the MHRA and UK Approved Bodies will most likely provide new sets of clarifications and guidance, making it critical for manufacturers to always keep abreast of new developments. The MHRA has already published guidance on some aspects of clinical trials that are another important area of attention for manufacturers, especially when these are carried out across multiple EU and non-EU sites.
Some additional key areas to keep under review include 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, labeling guidelines, documentation, and data exchange protocols, as well as any emerging UK-EU equivalency. The volume of work required to ensure compliance across countries and in such a dynamic environment is clearly high, but thorough planning and relying on past experience for EU MDR and IVDR, medical device businesses can rise to the challenge effectively and perhaps even realize unexpected commercial objectives.
This article was written by Ed Ball, Senior Associate, RQM+, Monroeville, PA. For more information, visit here .