The frequency of unannounced audits of medical device manufacturers in the European Union (EU) is increasing, according to comments made by the European Commission in June 2014. By April 2014, more than 40 Notified Bodies, designated by EU Member States to ensure that manufacturers conform to medical device directives, “had or were finalising procedures, and most were launching trials or had carried out real audits” of device manufacturers, the report states.
The reason for the audits? Manufacturers, importers, and distributors of medical devices such as intraocular lenses sold on the European market are required to provide data on their products’ safety and efficacy—before and now after their devices gain approval—according to revised EU medical device regulations.
As a result of recent scandals, these regulations are being strengthened and better enforced. Failure to comply has resulted in products (including previously approved products) losing their certification and being pulled from the market.
Manufacturers who find efficient ways to comply with emerging regulations will enjoy the benefits of public confidence, increased transparency, and abundant clinical data demonstrating the safety and efficacy of their products.
For continuous updates on the revised EU regulations and to learn about a turnkey solution for compliance, visit phaseiveyecarestudies.com.