Intraocular lens are very common in the treatment of Cataract. An Intraocular lens (IOL) is an artificial lens inserted during cataract surgery to replace the natural lens. It also may be surgically inserted as a method of vision correction that leaves the eye’s natural lens intact.
Surgery for cataracts involves removing the natural lens of the eye that contains the cataract and either replacing it with an artificial lens called an Intraocular lens implant (IOL) or compensating for its absence with eyeglasses or contact lenses.
Mainly two types of Intraocular lens (IOLs) are available in the market, Hydrophilic and Hydrophobic Intraocular lens (IOL) and the Materials used are, PMMA & PHEMA.
In case of Medical Device CE Marking for the Intraocular lens, we have to consider the requirements as per European Medical Device directive and the standard applicable for the Intraocular lens including testing. File should submitted to notified body for conformity assessment as per of MDD 93/42/EEC .Before starting the CE Marking -Technical file preparation we have to conform the Followings;
- What is the classification and rules in Medical Device directive for IOLs .
- List out applied standards applicable directives and harmonized standards for IOLs
The IOL technical file for CE Marking Should Include following Details
- The company Details like Address, location, Premises plan, Authorized Person for contact, European Authorized Representative Address, and a legal documents to Prove the company details.
- The Device Details like , exact name of the device ,indented use ,Mechanism of action, Packing details , storage condition. We have to attach the specimen IFUs, labels , outer carton and shipment labels etc. The label should comply with the Requirement of ISO 15223-1.
- The Device Manufacturing Details including clean Room atmosphere and sterilization a most important part of technical file. In case of sterilization Process we have to submit the control procedure, validation reports to prove the efficiency of the clean room and the Sterilizer(should consider the standard ISO 17665-1 for steam sterilization and ISO 11135 standards) . we can do the validation through the Recognized External Agencies. In this portion also should have a complete description about the incoming, in process and final inspection in order to prove the safety and Quality of the product.
- The Technical file should have the Risk Assessment Portion as per the standard ISO 14971. In this we have to analyze the possible errors that may be occurs during the usage and give an account that how it can avoid or minimize. This can be given as a warning or caution in the Product In sheets.
- The Biocompatibility Testing Reports of Intraocular lens includes Cytotoxicity studies(ISO 10993-5) ,local effect on implantation(ISO 10993-6) ,ETO residue testing (ISO 10993-7)and systemic toxicity (ISO 10993-11).these Test Reports are mandatory in CE Marking. We have to submit the Clinical Evaluation Reports with the Technical file for CE Marking.
- Should submit the Accelerated stability study reports to prove the stability of the IOLs
- The technical file should have a general description about the purchase process , critical raw materials and their approved suppliers. Attach the material safety data sheet for each material.
Malesh M
Regulatory Consultant
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Health Care Regulatory and QA Consultants 