Effective Clinical Evaluation Preparation Enables EU MDR Compliance

A European ophthalmology medical device firm, boasting numerous devices already approved and available in the European market, faced the task of aligning itself with the European Union (EU) Medical Device Regulation (MDR) that was enacted in 2017. This new regulatory framework, the EU MDR, governs the manufacture and distribution of medical devices in Europe, making compliance an essential requirement for companies wishing to sell or continue selling their products in the European market. As the original compliance deadline of May 2024 approaches, the European Commission has introduced a proposal to extend the transition period.

To maintain the CE marking (Conformité Européenne) on their devices and demonstrate continued adherence to all relevant health, safety, and environmental regulations in Europe, thus enabling them to continue selling in the European market, the company needed to submit comprehensive clinical evaluations in the form of Clinical Evaluation Reports (CERs) for all devices currently available in Europe. Failure to complete these evaluations and achieve compliance would eventually lead to the removal of their products from the market.

Uncover how Halloran was able to ensure that the company's European products remained on the market by meticulously preparing high-quality Clinical Evaluation Reports (CERs) for submission to Notified Bodies.