- The European Commission on Friday published a document from the Medical Devices Coordination Group (MDCG) that urges clarification of an article in the new Medical Device Regulation covering criteria for exemption of devices from involvement with expert panels.
- In Article 54(2), it is unclear whether the phrase "device already marketed" refers to products already marketed under old directives or uniquely under the MDR, the group said.
- The group, made up of EU member states, said clarification of the issue is "extremely urgent" because it is about to roll out procedures for establishing expert panels.
Phasing in of the MDR is under way and a work in progress. The MDR tightens controls for the safety and performance of medical devices in the European Union, which has cited problems with breast implants and metal hip replacements as a catalyst for the regulatory overhaul.
The new rules also are intended to reflect the technological and scientific advancements in the sector over the past two decades. They establish an EU database for devices called EUDAMED, an identification system based on a unique device identifier to improve traceability, a patient implant card system, and a financial mechanism to ensure patients are compensated if they receive defective devices.
For medical device manufacturers, products must complete recertification by a May 2020 implementation date to continue European sales. Diagnostics companies have until May 2022 to comply.
For certain high risk devices, the new regulations require European countries' notified bodies to consult with an expert panel before a device can be placed on the market. A notified body is an organization designated by an EU country to assess products before they can be marketed.
Under this procedure, an expert panel could provide a scientific opinion to the notified body on its assessment. While the notified body would not be bound by the opinion, it would have to provide a justification for not following it. All relevant documents regarding the opinion and the final decision of the notified body would be publicly available in EUDAMED.
The MDCG was created to enforce the new medical device and in-vitro diagnostic regulations, and its representatives come from all EU member states. In its document on Friday urging clarification of the meaning of "device already marketed," the group said it believes the expression is not intended to mean devices marketed uniquely under the MDR.
"As we are about to launch the procedures for the establishment of expert panels, clarification of this issue is extremely urgent, notably due to its impact on the future workload of panels and hence on relevant budget and workload estimations," MDCG said.