The road to regulatory approval for ophthalmic products is increasingly complex. You’re navigating strict timelines and changing global standards, and discovering the technical risks that come with testing intricate combination products. Knowing when to start testing, how many samples are required, and what regulatory pathway to follow is often unclear. Missteps can delay filings, inflate costs, and stall your device development. The Eurofins Medical Device Services network of laboratories offers a complete suite of ophthalmic testing solutions to move your medical device forward with confidence - on time, on budget, and in full regulatory compliance.

Whether you're developing a device, a drug, or a combination product, our scientists can support you with a broad range of testing, from chemical characterisation of degradation products, and extractables and leachables testing, to toxicological risk assessments and biological evaluations. Our expertise spans across all types of ophthalmic delivery systems, such as topical eye drops, solid inserts, injectable implants and contact lenses. 

For combination drug-device products, we offer tailored testing in alignment with regulatory guidelines and industry standards. With recent regulatory changes, like the reclassification of dispenser-packaged ophthalmic drugs as combination products, early partnership is more critical than ever. Eurofins Medical Device Services can help you interpret regulatory guidelines, compile Design History Files, and submit a successful request for designation (RFD) when needed.