New EU med device legislation targets safety, improved coordination
In an effort to re-vamp medial device regulations, the European Commission (EC), the executive body of the European Union responsible for proposing legislation, unveiled new legislation aimed at strengthening the safety of products and better coordination between the Commission and it’s Member States. While the European Union’s (EU) lenient product regulations often make it the first market for new medical devices, a 2012 scandal involving defective breast implants from a French manufacturer prompted the EC to re-examine it’s standards. While some safety measures have been successfully implemented since the scandal, EC officials felt the need for further action, acknowledging that “some key improvements . . . require a reinforced legal basis.” In response, the EC has developed a new action plan introducing several changes to the laws in order to improve product safety and consumer confidence. Earlier this month, the Employment, Social Policy, Health and Consumer Affairs Council (EBSCO) of the EC issued approval of the legislation and called for policy adoption to begin throughout other EU Member States by the end of this year. Regulations would not take effect until 2017 or 2018.
Along with strengthening the collective efforts and coordination of Member States, the EC said the new legislation focuses on market surveillance, transparency, regulatory governance, obligations of notified bodies, clinical evaluation, risk classification of devices, the reporting of incidents and the traceability of devices. Since the announcement of the plan, many EU Member States have conducted audits of their notified bodies. Twenty-two of the 23 Member Countries have performed qualification reassessments that have led to corrective measures of certain Member Countries’ activities, certificate suspensions and withdrawals, and operational changes. An additional 20 to 25 audits are expected to take place this year, and Member States may conduct unannounced audits of medical device manufacturers. WGA will continue to monitor and report on the legislation’s development as it unfolds throughout the year, particularly as it relates to compliance standards and future audits.
About the Author
Amy Sinclair is an Executive Vice President and co-leader of the Life Sciences Practice in WGA’s Property and Casualty Group. She negotiates, implements and manages comprehensive insurance programs for a variety of clients, ranging from venture-backed start-up organizations up to publicly traded companies.