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.”