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Impact of mandated post-market surveillance studies on the certification of ophthalmic devices in Europe

Poster Details

First Author: M.Mrochen SWITZERLAND

Co Author(s):    M. Talary   Y. Huang           

Abstract Details

Purpose:

To examine the impact of post-market surveillance requirements on the certification of ophthalmic devices in Europe.

Setting:

Institut für Refraktive und Ophthalmo-Chirurgie, Zurich

Methods:

We examined the potential impact of increasingly strict application of European medical device regulations on the certification, cost, and availability of one class of ophthalmic product, intraocular lenses, in the European market.

Results:

More strict application of the guidance documents for compliance with European medical device regulations for post-market surveillance may increase the cost of introducing and maintaining certification of ophthalmic products such as intraocular lenses in the European market.

Conclusions:

Medical device companies intending to release or maintain existing medical devices within the European market should be aware of the impact of more strict application of EU regulations on their businesses. Post-market surveillance requirements may increase the cost and decrease the availability of certain ophthalmic devices in Europe.

Financial Disclosure:

NONE

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