One year into the transition periods for the new EU medical device and in vitro
diagnostic (IVD) regulations, and not a whole lot has occurred to help companies implement the new regulations, experts said Wednesday in Brussels at RAPS' workshop
The three-year countdown to the new EU Medical Devices Regulation’s (MDR) full application in 2020 (and five years for IVDs) has created an anxious environment for companies, particularly as for most legacy devices (CE marked under the previous device directive), a review of Annex I, General Safety and Performance Requirements, will identify
new conditions that will need to be addressed. Clinical data, technical documentation and labeling also will need to be updated.
Oliver Bisazza, director of regulations and industrial policy at industry group MedTech Europe, lamented that “not a whole lot” has been put in place in terms of what’s necessary to implement the new regulations and “most of the useful stuff is still to come.”
Most recently, the European Commission released guidance (see bottom of article for links) on the possible structure for the unique device identifier (UDI) database and UDI core elements, as well as more information on device nomenclature
But one of the biggest changes that companies are anticipating is related to the requirements for more clinical data to bring new devices to market – which the European Commission has yet to issue guidance on – and to keep legacy devices on the market (a constant refrain from the experts at the conference: No devices will be grandfathered into the EU market under the new regulations).
“Everyone is looking into what those final clinical evidence rules will look like – from industry point of view, we want a pragmatic approach for legacy products,” Bisazza said.
One of the issues is that for products that have been on the market for a long time, running a new clinical trial and acquiring the data necessary to keep the device on the market may not even be ethical.
“The risk is we lose legacy products,” Bisazza added. “Once products are retired, it’s not like turning a tap back on – what the [European Commission] comes up with needs to be understood well in advance of the implementation dates.”
Another issue causing concerns among companies, according to Sophie Tabutin, BSI notified body regulatory lead, is that for some higher risk implants, where the device is demonstrated to be equivalent to an already marketed device, the two companies will need to have a contract in place to allow access to technical documentation on an ongoing basis.
“Getting your competitor to give you access to all of your data on an ongoing basis seems difficult, almost impossible,” Tabutin said. A quick poll of attendees showed none had established such a contract.
As to whether the implementation deadlines may be pushed back, Bisazza and an informal poll of the meeting’s attendees showed skepticism. Questions also linger
on whether there will be enough designated notified bodies.
“Touching the legal text is a last resort,” Bisazza added.
UDIWG 2018-1 UDI database. Definitions, descriptions and formats of the UDI core elements
MDCG 2018-1 Draft guidance on basic UDI-DI and changes to UDI-DI
UDIWG 2018-2 The architecture of the UDI database - Basic UDI-DI and UDI-DI attributes for medical devices and in-vitro diagnostic medical devices
Medical Device Coordination Group (MDR/IVDR) DRAFT AGENDA (version 1)