EU Medical Device Regulations: The Key to Compliance

European manufacturers of implantable ophthalmic devices now have a turnkey solution for complying with EU medical device regulations.

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. As a result of recent scandals, these regulations are being strengthened and enforced, such as by unannounced audits. Failure to comply has resulted in products losing certification.

To meet the need for phase IV clinical studies that generate data conforming to European regulators’ specifications, Zurich-based IROC Science to Innovation AG, a leading ophthalmic consulting service with specialized expertise in ophthalmic clinical trials and extensive knowledge of the European regulatory landscape, has teamed up with EyeKor, LLC, a company of American clinical trial experts that has developed a cloud-based software application, EXCELSIOR™, built for image data collection and management of ophthalmic clinical trials.

According to IROC’s Founder and CEO Michael Mrochen, PhD, “The burden that the regulations place on the makers of implantable devices is significant, so it was important to create an efficient way for companies to obtain postmarket outcomes data.”

EyeKor CEO Christopher J. Murphy, DVM, PhD, notes: “Excelsior™, EyeKor’s unique ophthalmic clinical trial software platform, enhances speed and accuracy in the collection and interpretation of ophthalmic trial data, making it perfectly suited to phase IV studies. It enables efficient uploading and archiving of images collected using diverse proprietary software to standardize the presentation format. Excelsior™ has received FDA 510(k) clearance with indications for use as a data management system for ophthalmic trials.”

How and Why to Comply With EU Medical Device Regulations

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.

How Will Your Business Be Impacted by New EU Medical Device Regulations?

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.