A key advisory group to the European Commission called for urgent clarification of certain device exemptions under Article 54(2) b of the EU’s Medical Device Regulation (MDR).
The article lays down three criteria that exempt devices from the premarket clinical evaluation consultation procedure involving expert panels.
The EU Medical Device Coordination Group (MDCG) said the commission’s guidance on the article is unclear and has raised concerns among EU member states.
As written, the exemption would apply “where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device.…”
MDGC said the interpretation of this article is unclear, notably the application of the word “marketed.”
The advisory group points out that in Article 54(2)a the certificates are referred to as those issued under the new regulation, but in Article 54(2)b, there is no indication of whether a device already marketed refers to devices already marketed under existing EU Directives or the MDR.
Timing is Critical
The timing is critical because new procedures are being launched for establishing expert panels, and the way the article is interpreted will have an impact on the future workload of expert panels as well as budgets, the group said.
The MDGC said that the “device already marketed” reference cannot be intended to refer to a device already marketed uniquely under the new regulation.
The group argued that if legislators had wanted to restrict the application of point “b” to devices marketed uniquely under the MDR, they should have explicitly stated that as they did for point “a.”
The group stressed that in respect to devices that have been marketed already under the relevant EU Directives, the word “modification” should be meant as “limited only to those modifications needed in order to comply with the new legal requirements introduced by the MDR.”
The devices will be subject to all applicable new MDR requirements, including those related to clinical evaluation and would need to be assessed by notified bodies against these new requirements, the MDGC said.
Read the notice here: www.fdanews.com/03-28-19-MDRexemptions.pdf.