EC's John Dalli Calls for Stricter Safety Controls, Postmarketing Surveillance for Medical Devices
Posted 10 February 2012 | By Alexander Gaffney, RAC
The European Commission's (EC) Commissioner for Health and Consumer Policy John Dalli called for the EC to "look at the sector of medical devices as a whole," saying that both the EC and national agencies need to review how medical devices are approved in the EU in a speech given to the press on 9 February.
"As you know, we had already been working on a revision of the Medical Devices legislation and within the context of the ongoing preparatory work we had included provisions, among others, on the strengthened supervision of notified bodies, clinical investigations, vigilance and traceability," said Dalli.
"[A]ll Member States, EFTA countries and Turkey, which is covered by a free trade agreement, must ensure that the requirements to be met by the independent notified bodies that are involved in the pre-market assessment of medical devices are rigorously and consistently applied," continued Dalli.
According to the Commissioner, notified bodies must "make full use of the powers given to them under the current directives," and unannounced inspections are an important component of their responsibilities.
Dalli further called for Member States to "reinforce their market surveillance activities," including unannounced inspections and product testing. Dalli said that the EC will be looking in to ways to coordinate these activities to prevent unnecessary duplication.
Dalli also called for an improved medical device vigilance system and a medical device traceability system to ensure long term safety monitoring of patients and their implanted medical devices. Dalli said that Member States are "in the process of establishing systems of Unique Device Identification (UDI)."
Politico reported last week that US efforts to implement this UDI to ensure harmonization across both the US and EU have been stalled by the Office of Management and Budget. Dalli's increased emphasis on this UDI system may risk a divergence in standards if the EU is pressured to release guidelines before the US releases its guidelines.