Manufacturers 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 EU medical device regulations that became law in April 2014. As a result of recent scandals, these regulations are being strengthened and better enforced, such as by unannounced audits. Failure to comply has resulted in products losing their certification.
“In the past, it had been possible to use existing data from previously published studies as proof of safety and efficacy,” notes Mark Talary, PhD, senior research and development consultant at IROC Science to Innovation AG. “Now, manufacturers have to show clinical data on their own devices. To maintain certification, they must adhere to a formal process for following the product after it’s on the market and providing ongoing safety and efficacy data.”
Previously approved products are also subject to the regulations and can be pulled from the market for noncompliance. “Medical devices need to be regularly recertified to maintain their Conformité Européenne mark, which means all devices will be audited in light of the new regulations,” Dr. Talary explains.
For a full list of the changes, see “Revision of the Medical Device Directives” on the European Commission’s website.