One of the biggest issues facing manufacturers of medical devices this year is the new Medical Devices Regulation (MDR). Responding to the concerns of members of FMO who manufacture, distribute and supply spectacle frames and spectacle lenses, we have appointed Ann Blackmore as a consultant. Ann will be attending EU meetings as well as providing regular briefing summaries. MDR is on the agenda for February’s Lens Focus Group meeting.
FMO is offering advice, confirming deadlines and providing links to EU guidance, which is constantly being updated. We are also summarising the latest position in the U.K. and the work of the UK regulator, the MHRA. We hope our updates will allow FMO members to steer through these new waters and give them an early heads up for what eventually comes down the line.
The EU Regulation on medical devices was published in 2017, with a 3 year implementation period, meaning it will apply fully from 26 May 2020. MDR has been incorporated into UK law, so it will continue to apply post Brexit, unless the UK government introduces changes, which is highly unlikely.
The aim of the MDR is to improve transparency and patient safety, creating a comprehensive database on medical devices (EUDAMED) and introducing the Unique Device Identification (UDI), which will make traceability of devices more efficient. The MDR requires manufacturers to register the UDI and associated information for all medical devices with EUDAMED.
Although during the transition period manufacturers have been able to place products on the market under the original Medical Devices Directive (MDD), from 26 May 2020 all devices placed on the market must conform with the MDR. However, devices which were already on the market in accordance with the MDD can continue to be marketed for a further 4 years.