With Little Movement on Device Regs, EU States Turn to Joint Action Plan

April 3, 2015

Lack of progress on medical device reform legislation has spurred some EU countries to use last year’s joint immediate action plan to improve device oversight.

Regulators using the joint plan will stay within the boundaries of existing legislation while coordinating vigilance activities such as recalls — something that has rarely happened in the past, says Erik Vollebregt, with Axon law firm in the Netherlands.

A joint market surveillance pilot program proposed in the 2014 action plan also seems to be moving forward and will allow member states to monitor postmarket experience “at an acceptable level,” Vollebregt adds.

The Joint Action Plan, issued last June, is best known for having permitted notified bodies to perform unannounced audits of manufacturers.

However, it also established monthly vigilance teleconferences between member states and directed the European Commission’s Joint Research Center to analyze trends in medical device incident reports.

The medical device regulations, proposed in September 2012, have been stalled since last year as the Council of Ministers struggles over a controversial premarket scrutiny mechanism and other provisions. It’s currently unclear when the legislation might move forward. — Elizabeth Orr