Internal Clinical Testing
Due to our vast range of CE Marked contact lens designs and materials,Â using our formal processes, we can self-certify CE Marking of productsÂ based on predicate devices and clinical evaluations.
This contributes to the fast and flexible approach we offer for rapidÂ prototyping and concept proving.
Route to CE Marking
We follow the route to CE Marking using clinical evaluation for Class IIaÂ medical devices and following the requirements stipulated in the
Medical Device Directives.
- Risk assessments based on our extensive experience with designs and materials
- Literature searches
- Internal clinical trials conducted in accordance with MHRA regulations and ethical approval guidelines
- External clinical trials commissioned from bodies such as Eurolens Research