Latest Medical Device industry trends from Medical Technology UK 2023
Medical Technology UK in Coventry is the exhibition and learning place for medical device engineers in the UK. The team at IMed Consultancy could not miss out on this key opportunity to mingle with over 130 specialist suppliers, with a large contingent of both young and female MedTech entrepreneurs, to talk about the future of medical technology innovation. Catching up with old industry friends and partners was of course another big driver!
This two day event is a staple for the UK industry and provides specialist presentations and well as a structured learning programme. IMed was keen to mix with our peers and take the pulse of the medical device industry.
Trends and issues driving the medical technology industry
In addition to typical requirements such as QMS support or CE marking support, some burning issues for the industry dominate: the effects of Brexit and the uncertainty surrounding the deadlines for the EU MDR and IVDR. These cast a shadow of insecurity for medical device manufacturers in the UK who may now need to comply with two sets of regulations (UK and EU) to maintain products in their traditional markets.
As a result, we’ve seen many manufacturers turn to the USA as a valid alternative to the EU market. This move often requires FDA submissions, and many are thus looking for specialist regulatory support in reviewing them to ensure they achieve compliance smoothly. At the same time, EU medical device manufacturers are looking for UKRPs as their current providers, often distributors and importers, are no longer able to offer the service under new regulations.
Notified Body capacity: a window of opportunity?
One interesting trend that is emerging concerns Notified Body (NB) capacity. One of the main concerns for the industry has been the need to engage with a decreasing number of notified bodies before EU MDR deadlines to avoid potential bottlenecks as these reach capacity.
Specifically, many manufacturers are still “orphaned” as they have not found a suitable NB to take them on or are at risk of becoming orphaned in the near future as NBs choose to retire. At the time of writing, six new notified bodies have received MDR designation since June 2022, creating a pool of 36 organizations that need to process a staggering estimate of 23,000 certificates in only a few short years, provided all existing devices remain on the market.
Chatter on the trade show corridors, however, suggests that certificate extensions have created gaps in the pipelines of some NBs which savvy medical device manufacturers would do well to fill with their products! Of course, as deadlines loom, this opportunity will vanish making it imperative for manufacturers that have not found a NB yet to act quickly and secure a spot.
European Commission, Notified bodies survey on certifications and applications, 26th October 2022, https://health.ec.europa.eu/latest-updates/notified-bodies-survey-certifications-and-applications-2022-10-26_en
Business Development Director