CE MARKING OF OPHTHALMIC BLADES

Ophthalmic Blades are Medical device used in ophthalmic surgery for making precise incisions and Sterilized by ETO. Intended for single use in ophthalmic surgery. The device is to be used by qualified and trained ophthalmic surgeon only. Different types of Ophthalmic Blades are used based on the comfort ability of the surgeons and required applicability in different types of ophthalmic surgical interventions. Classification : Class IIa

Justification of Classification: As per section 2.2, Rule 6 of Annex IX of MDD– All surgically invasive medical devices intended for transient use are in Class IIa

In case of CE Marking for the Ophthalmic Blades, consider the requirements as per European Medical device directive and the standard applicable for the Ophthalmic Blades including testing. The Ophthalmic Blades technical file for CE Marking should consider the following standards

ISO 15223-1

ISO 17665-1

ISO 11135

ISO 14971

The Biocompatibility Test  Reports  of Ophthalmic blade includes Cytotoxicity studies(ISO 10993-5) ,ETO residue testing (ISO 10993-7)and systemic toxicity (ISO 10993-11)

File should submitted to notified body for conformity assessment as per of MDD 93/42/EEC.

Malesh M

Regulatory Consultant

I 3 Consulting

+91 9900 3218 14