I have a running dispute with a certain well known contact lens solution manufacturer regarding a product recall. They claim a 7 day response to all product recall claims but failed by over 3 weeks to achieve this on my claim. I cheekily questioned if they would be raising this as a deviation in their QMS, and when I didn’t receive an answer for another 4 weeks, I decided to make a formal complaint. I have now been advised by their customer services team they have no formal customer complaint procedure!
I wonder then if the company is regulated as I understood contact lenses and solutions are classed as medical devices, so should be manufactured under GMP and they should have a suitable QMS in place.
Here are some answers that were shared by industry experts:
According to Medical Device Regulation (#MDR) 2017/745 Annex VIII, Rule 16 “All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb. ” So yes, it is a medical device.
If they place their, by EU definition and regulation, medical device (contact lense solution as clarified by Angelina) on the EU market and they do not have a formal complaint handling procedure, they are clearly in violation with EU MDR 2017/745. They are then not complying to Article 10.9 (i), (k) and probably also (j), all of which are fundamental to the compliance of the MDR. More details to be found in Article 83.
Truly worrying. If it is registered as a class II medical device then they will have to have a quality system in place which usually includes a designated person responsible for regulatory compliance (PRRC). This person should be on top of post market surveillance (device equivalent of pharmacovigilance) otherwise it is I believe punishable by fines.