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Survey about modification of RGP contact lenses at the point of care under MDR

This survey aims at exploring if and how, under the EU Medical Device Regulation (MDR), rigid contact lens are modified* by an Eye Care Professional after they have been placed on the market by their manufacturer. This survey is anonymous.

Indeed, EuromContact is drafting a note to explain the legal consequences of such practices now that MDR is fully implemented. To support this work, EuromContact seeks feedback from manufacturers to understand whether these practices are anticipated and how they are viewed by notified bodies.


* "Modification" covers actions such as polishing the surface, adding coating, flattening the back-surface periphery, veneering the back surface periphery, improving the edge, reducing the edge thickness, rounding edge, reducing diameter, ventilation hole.

 


Secured
1

Do you supply rigid contact lenses in the EU as a "manufacturer" as defined by the EU Medical Device Regulation (MDR)?

Select one answer
2

Are you aware about modifications performed on your RGP lenses by third parties (ECP) during the fitting process ?

"Modification" covers actions such as polishing the surface, adding coating, flattening the back-surface periphery, veneering the back surface periphery, improving the edge, reducing the edge thickness, rounding edge, reducing diameter, ventilation hole.
3

Do you keep record of such changes ?

Select one answer
4

To your knowledge, what type of modifications are made to your contact lenses ?

Select one or more answers
5

Based on your experience, what percentage of your lenses are modified by eye care professionals after being placed on the market ?

Indicate the %
6

Do you release methods for the modification of contact lenses in your IFU or during fitting training?

Select one answer
7

Do you provide specific limits for the modification of contact lenses in your IFU ?

8

Are there clear training requirements for persons defined who carry out the modification of Contact lenses?

Select one answer
9

Do you provide guidelines for the cleaning of your contact lenses (incl. frequency and released cleaning supplies)?

Select one answer
10

Did you get any feedback from your Notified Body regarding the possibility for a distributor (Eye Care Professionnal) to modify your contact lenses after they have been placed on the market ?

Thank you very much !