A key advisory group to the European Commission called for urgent clarification of 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 commission’s guidance on the exemption is unclear, notably how it defines the term “marketed.”