COVID-19 Could Bring Welcome Relief to Ireland’s Burgeoning Medical Device Industry

The medical device sector is one of Ireland’s largest commercial sectors accounting for 32,000 direct jobs and over €12.6 billion in exports. In fact, Ireland is now one of the world’s global hubs for the sector. However, it has been struggling in recent times with huge potential consequences on several fronts. Reputationally for Ireland, commercially for the sector and, most of all, the health of the European Union’s 447 million citizens across its 27 States (post Brexit).

Well before the COVID-19 virus reared its head, the sector was already facing a once-in-a-generation upheaval due to the introduction of new legislation – the Medical Device Regulations (“MDR”) which came into force three years ago in 2017 and becomes fully applicable on 26 May this year.

As the Coronavirus continues to spread throughout Europe and governments take increasingly severe measures to minimise its impact through the restriction of movement and gathering of people, we look at how the medical device industry, and the regulatory framework which surrounds it, may get an unexpected lucky break as a result of the rapid spread of the virus across the EU.

The Race for Device Certification

Medical device manufacturers and Notified Bodies (the organisations designated by EU countries to assess the conformity of medical devices before they are certified and placed on the market) have for three years been engaged in working towards having their products approved or their organisations designated under the new standard, MDR, in advance of the 26 May 2020 deadline.

There are thousands of types of medical devices that people, including EU citizens, depend on for the health and quality of life and that medical professionals depend on to provide services. This new legislation covers everything from bandages, syringes, catheters, insulin pumps and cardiac pacemakers to literally thousands more devices. All of them have to be approved to the highest possible standards for sale in the EU and MDR is the new ‘standard-bearer’ for the EU taking over from the previous legislative standard – the Medical Device Directive (MDD), which has been in force since 1993.

Re-certification Bottleneck

The scale of the exercise, which not only requires the approval of so many products but the creation of adequate approval capacity in the form of the Notified Bodies, has resulted in serious bottlenecks with a little over two months left to the deadline. Owing to this uncertainty, most manufacturers have sought to capitalise on an extended period of grace by securing certificates issued under the old legislation, MDD, before 26 May 2020. Securing such a certificate in time provides manufacturers with a de facto 4 year extension up to May 2024 (at the latest) for bringing all their devices/clinical data into compliance with the MDR.

These MDD certificates would keep many thousands of medical devices on the EU market, that would otherwise have to be withdrawn from sale with significant consequences for patient care. Right now, many manufacturers are hedging their bets by applying for certificates under the old (MDD), as well as under the new (MDR) legislation.

With the medical device regulatory system in the EU already working at capacity to deal with the advent of MDR, the added pressures and effects of COVID-19 is highly likely to overload the regulatory system completely.

Notified Body MDR Designation

At present, a total of 11 Notified Bodies are designated to assess the conformity of medical devices under MDR throughout Europe. There are a further 10 Notified Bodies whose designation is still ‘pending’ so they cannot assess and certify devices as being MDR-compliant. The significant number of bodies that are merely pending MDR designation has already caused capacity issues in the EU’s regulatory system. With COVID-19 threatening to shut down or severely restrict many work environments across Europe, perhaps for a number of months, it is uncertain whether the pending designations will be made in sufficient time in advance of the full application of MDR on 26 May 2020.

In the likely event that further MDR Notified Body designations are not achieved in advance of 26 May 2020 due to the expected impact of COVID-19, the EU Regulatory Framework would simply not have sufficient capacity to assess medical devices for MDR conformity in a timely manner, thereby further fuelling the growing calls for the date of MDR application to be postponed.

With the medical device industry and their regulators already struggling to ensure a smooth transition from MDD to MDR,  the cloud that is COVID-19 could have a silver lining of sorts for the industry and most importantly for EU citizens if it forces the delay of MDR application into 2021 or beyond. If not, then the irony will be that the mother of all supply chain disasters in 2020 will not be directly attributable to COVID-19. The ultimate decision rests with the EU Commissioner for Health &Food Safety, Lithuania’s Stella Kyriakides.

How we can help

BHSM’s Healthcare and Life Sciences Department offer practical legal and regulatory compliance advice to a variety of clients across the medical devices sector.

For further information on how the introduction of the MDR may affect your business, please contact David Scott in the Healthcare & Life Sciences Department of BHSM on 01 440 8300 / dscott@bhsm.ie.

This article is for general information purposes.  Legal advice must be obtained for individual circumstances.  Whilst every effort has been made to ensure the accuracy of this article, no liability is accepted by the author for any inaccuracies.