Adam Stanley examines how Brexit and COVID-19 have conspired to shape the future of the regulatory market for medical devices in the UK.
The way in which all dental and medical devices are approved for sale on the UK market is about to change.
That statement could also have been made a year ago as the industry prepared for a move to a revised European Union regulatory framework. But intertwined developments around COVID-19 and the Brexit transition period have meant that we are now heading toward a new, sovereign system for the UK.
Missing the MDR window
In fact, dramatic regulatory change for dental and medical devices has been on the horizon for a number of years.
The regulation of such devices has, since 1992, been governed at an EU level by the Medical Device Directive (MDD). This sets out the requirements for CE marking before a product can be brought to market.
In the wake of reports of scandals involving high failure rates of implanted devices, notably metal-on-metal hip replacements and Poly Implant Prothèse silicone-based breast implants, the way in which medical devices as a whole were regulated came under scrutiny.
The result was a new piece of EU legislation, the Medical Device Regulation (MDR).
Until earlier this year the dental industry had been preparing for MDR implementation in the UK, which had been to take place on 26 May 2020.
Despite the UK having left the EU on 31 January 2019, the Transition Period had meant that the MDR would be captured by the Withdrawal Act regardless. Therefore it would form the basis of the UK’s regulatory framework outside of the EU.
That, like so many best laid plans of 2020, didn’t happen.
COVID-19 saw the EU machinery of MDR implementation grind to a halt. It became clear that the existing deadlines had become unachievable.
The European Commission, responding to widespread calls for action and to avoid disrupting the supply of essential medical supplies, announced a 12-month delay to the MDR’s date of application. This postponement took it to 26 May 2021 and out of the Brexit Transition Period.
Suddenly, MDR would no longer apply by default in the UK, and our government was faced with deciding on a new course of action, developing a UK-specific regulatory approach and then implementing it – all in only seven months.
Enter the UKCA
Still, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) had not indicated any appetite for significant departure from the MDR. This was expected to form the foundation of our domestic legislation. Discussion of a new UK Conformity Assessed (UKCA) mark as our sovereign equivalent of the CE mark had emerged in 2019. At the time medical devices were explicitly excluded.
A few turbulent months later and September saw the MHRA publish details of its new approach. Confounding previous expectations, this revealed that MDR would no longer underpin our regulation. Also, that the UKCA mark would indeed apply to medical devices.
The UK’s regulation is to be based on the existing MDD. Although, further changes are likely to be made through the new Medicines and Medical Devices Bill. This is set to afford the government a range of new powers around regulation, enforcement and traceability.
Changes and challenges
So what will this mean from the perspective of the dental profession? Initially, at least, things will remain relatively unchanged. This is not a cliff-edge scenario and recognition of the CE mark until 30 June 2023 means that dental products can continue to be sold in much the same way as they had been when the UK was a member of the EU.
Behind the scenes, however, there is an enormous challenge for the industry. Two and a half years, while welcomed, is not a long time when considering the task at hand.
By 1 July 2023, every medical device on the Great Britain market will need to display the UKCA mark. After having gone through the necessary certification processes. For all but the lowest risk classification of devices, this requires the involvement of a third-party conformity assessment body.
The number and capacity of such bodies has long been a concern at an EU level. It has worsened as they have been required to undergo a redesignation process to certify products under the MDR. The strain on capacity was so pronounced that the European Commission issued a communication to healthcare professionals. They were warned of the possibility of disruption to the supply of some devices.
The challenge will, in large part, be one of bringing enough of these UK approved bodies online before CE certification stops being recognised in Great Britain. In such a way that will allow certification to take place for the hundreds of thousands of products that require it. Also, without damaging effects on cost and availability.
One size does not fit all
Specific references to the Great Britain market, as opposed to that of the UK, are not a mistake; different rules will apply in Northern Ireland as a result of the Northern Ireland protocol.
Northern Ireland, in contrast to Great Britain, will follow EU rules. By implementing the MDR and continuing to use the CE mark.
This means that two different regulatory regimes will cover medical devices in the United Kingdom at once. Three, in fact, while the MDD is still in effect until 26 May 2021. Combine these complexities with existing Brexit concerns around hauliers and the potential for delays at key ports. Companies will be carefully assessing their approach to this market. It is clear that the supply of dental and medical devices to Northern Ireland will look different.
While the challenges are significant, the move away from EU regulation is not without its opportunities. As noted, MDR implementation has been fraught with difficulties of its own for some time. The vast majority of UK device companies will still need to ensure CE compliance for the EU market. However the move does give the UK a degree of flexibility.
The benefits of an agile, forward-thinking regulator are seen in the MHRA’s work on the coronavirus vaccine programme. Industry will be keen to see an innovation-friendly approach taken. One that enables products to be brought to market in a timely fashion.
The MHRA has also indicated its intention to be an active participant in the international regulatory landscape. This positions the UK as an attractive place to bring new products and innovations. It would be a positive outcome of the new framework for the industry, profession and patients alike.
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