For those looking to bring a medical device to market in the EU, relying on past experience and strategy will no longer make the cut. With the added uncertainty of Brexit and new EU regulations in the form of the MDR/IVDR, everything is about to get much more complicated.
So what’s about to change?
Replacing the 1993 Medical Devices Directive, the new Medical Device Regulations (MDR) has been a long time coming and is set to be fully implemented by 2020. The new document will include stricter requirements in relation to clinical evaluation and improvement in the traceability of devices through the supply chain. Ultimately however, it seeks to bring better safety and performance to all medical devices.
When the In Vitro Diagnostics Directive (the current legislation) was written, the industry was in a stage of infancy. As this industry evolved, the legislation unfortunately didn’t. As a result, the arrival of the In Vitro Diagnostics Regulations (to be fully in place by 2022) is intended to bring the legislation in line with the growing industry. In the past, manufacturers could classify their own products and self-certify. That will no longer be possible and 90% of certifications will now require the involvement of a notified body.
Here’s the bad news: Following our departure from the EU, notified bodies will no longer be able to operate from within the UK and will be required to move their offices into the EU. For manufacturers located outside the EU, the presence of an EU based authorised representative will be crucial in securing compliance with the new European legislation.
A recent collaboration of 3form Design with Meddev Solutions is a unique example of how UK innovators can be continue to flourish amidst these issues. As Meddev are based in the Republic of Ireland, they can guarantee support in post Brexit Europe through EU Authorised Representation. This collaboration enables a “One-Stop-Shop” for developing and selling medical devices. Design for manufacture and delivery to market with full regulatory support is a rare offering, and can give enormous peace of mind to the innovators within the Medical Devices industry.
Whether these new regulations are welcome or not, they’re set to be implemented within the next few years so significant changes will be necessary. In a Med Tech article from earlier this year, journalist Paul Brooks writes this:
“Manufacturers with strong regulatory resources, intelligence and structure will be much better prepared to navigate the new regulations, and these well-prepared companies will, no doubt, position themselves as the most competitive in the market.”
With the recent possibility of a no-deal Brexit, it’s imperative that the UK medical industry realises its status in global markets and fosters partnerships such as that of 3fD and MedDev. In doing so, we can continue to deliver both innovative products, and innovative regulatory strategies to the EU.