Medical Device companies fear that Britain’s exit from the European Union could result in a “parallel” regulatory system which would require them to file separate applications to access the U.K. and E.U markets, according to a new report from ScienceBusiness.
Only 2 weeks ago, the Environment, Public Health and Food Safety Committee of the European Parliament and Council’s Committee of Permanent Representatives voted to endorse new medical device and in vitro diagnostic regulations.
The approval paves the way for for the adoption of 2 new draft regulations by the end of 2016, though the new rules would not take effect for 3 years in relation to medical devices and 5 years for IVD. The regulations cover the design, manufacturing and clinical testing of medical devices and in vitro diagnostics, and will affect all device manufacturing and sales in the E.U.
Whether those regulations will now apply to products in the U.K. is still uncertain, according to the report from ScienceBusiness.
“From a business perspective it is hard to see an upside to the UK’s decision to leave the EU. Britain’s influence in the development of the European MedTech regulatory environment has been extremely positive and we now face an uncertain situation with possible regulatory divergence over time,” Cook Medical EMEA exec veep Bill Doherty told ScienceBusiness.
Currently, medical devices can be marketed throughout the E.U. with only CE Mark approval by any of the approximately 70 notified bodies which are overseen by national regulators.
“It’s a question of what they will be able to rescue from the wreckage. If a deal cannot be done, device manufacturers would need to go through approval twice, once for the U.K. market and once for the EU market, and I don’t see any value in that for anyone,” U.K. Health Research Authority research ethics advisor Hugh Davies told ScienceBusiness.
Davies said he expects the country will try to keep things “as harmonised as possible,” which would allow for the mutual recognition of U.K. and EU notified bodies, with the U.K. following the previously agreed upon rules and regulations.
“The U.K. MHRA has been incredibly influential in leading on so many aspects of how healthcare products are regulated. Now we are marginalized. We may be invited to the table but won’t have a voice,” Davies told ScienceBusiness.