In February this year, the government released guidance explaining that, regardless of the outcome of Brexit negotiations, the UK will adopt its own version of the EU’s Medical Device Directive in the form of the UK Medical Device Regulation. Here, Hetal Patel, marketing project manager for Advanced Engineering, explains why the medical device industry needs to put uncertainty to one side and focus on leading the way in adhering to the regulation.
Most of us can appreciate the need for the regulation of medical devices due to their importance in people’s lives. For medical devices, quality and safety are paramount. Medical professionals rely on devices that consistently perform reliably and safely without putting their patients at risk.
The success of this, however, depends on a forward-thinking manufacturing sector, combined with a progressive regulatory landscape. Engaging, medical device manufacturers, that proactively encourage innovation must be combined with legislation set by policy makers that keeps pace with the latest innovations in the sector.
In the past, all the laws regarding the manufacturing of medical devices were harmonised throughout the European Union under the Medical Device Directive (MDD). Products that conformed with the MDD were labelled with a CE mark. The intent of this mark was to provide a certification of quality and reliability that could be trusted.
Now, to allay uncertainty regarding the outcome of Brexit, the UK has pledged to replace the MDD with the new Medical Device Regulation (MDR) regardless of the outcomes of Brexit negotiations in order to provide clarity and, more importantly, certainty for medical device manufacturers.
The implementation of the MDR brings with it several changes to the rules surrounding medical devices within the UK. One key change is that, unlike the MDD, the MDR is a regulation and not a directive meaning that it is easier to enforce and less open to differing interpretations. This can only be a positive thing for manufacturers as it will provide new, increased levels of clarity in legislation.
Other changes that will come from switching from the MDD to the MDR include stricter premarket review of high-risk devices, strengthened designation criteria for notified bodies, improved traceability, as well as a risk-based classification system for in vitro diagnostics (IVDs).
The truth is, despite any upcoming changes to legislation, if the medical device manufacturing industry continues to promote innovation and invest in research and development then it can stay ahead of the curve. After all, the medical device manufacturing industry is one that has traditionally been proactive, rather than reactive, in finding ways to adapt to new scientific and technological advances, going above and beyond the basic requirements set out in law.
We’re confident that the medical sector will respond well to the MDR and sidestep any short-lived political uncertainty. To showcase the best that the UK has to offer, this year’s Advanced Engineering show will be co-located with Medical Device Engineering, the new national event set to launch on the Advanced Engineering trade show floor in 2019.
At the event, Stuart Grant, senior manager at DePuy Synthes, which is part of the Johnson & Johnson family of companies, will present a talk on the impact of the MDR and discuss how medical devices need to respond to the new legislation.
There will be exhibits covering all aspects of the medical industry, from anaesthetic technology and wound care management, to implantable devices and digital health, and lots more. This diverse platform will include representatives from companies such as Xi Engineering, which will host a session on wearable technology, and academic establishments such as Trinity College, Dublin, which are there to discuss the next generation of implantable devices for tissue regeneration.
To see the latest in cutting edge technology for use in medical devices, visit Medical Device Engineering on the Advanced Engineering floor. To find out more about both shows, visit the website at: www.advancedengineeringuk.com