Over the last couple of years we have worked very hard to transition from the Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). All of our hard work has now been handed to our notified body, and they have reviewed our Technical file and our on-site audits have been completed. Disappointingly, we have been informed that the time frame to receive our new MDR certification could take 2-3 months past our certificate expiry.
We are committed to pushing forward to do everything in our power to speed up our notified body so that we receive our certificates before the end of 2022. With immediate effect, SOFT and RGP custom-made devices can now be ordered from us. This has been approved by our new EC-REP, better known as a European authorised representative. From Wednesday 9th November 2022, our EC-REP is Cantor & Nissel (Ireland). The address and contact details can be found below.
Unit 8, IDA Business Pk, Dunleer, Louth A92D252 IE.
We still have a strong Quality Management System in place and hold our certification for the ISO 13485 and the 2 FDA 510k’s which are held for the Cantor Prosthetic and Nissel Custom. We have also acquired the new UKCA marking. Our custom-made lenses will conform to all of the above as we continue to manufacture under what will be the new MDR, offering you the confidence that our lenses remain manufactured with the highest standard of quality. In addition to this, as Custom-Made Devices, our SOFT and RGP contact lenses will be available in a far wider range of configurations.
How this affects you
When ordering there is a requirement to have the name of the prescriber for each order, along with a patient name or identifying number (If you don’t already). If you have an eye care professional that holds the relevant qualification within your company, we can hold their qualifications on file and use them if you prefer.
It is possible that you may experience a small delay on your orders as we will not be able to use any stock. Lenses will be manufactured once your order has been received. We will do everything we can to ensure these delays do not happen.
The label on our vials and RGP mailers will also change to show that the lens is custom-made for a specific patient, with each order being signed off by our Quality Assurance and Regulatory Affairs Manager. As a custom-made device, there is no requirement for a CE mark to be affixed to our label or accompanying documents.
This will be a temporary situation and we are hoping that you will have no objection with helping us with our short term solution to supplying our lenses.
Have any questions?
If you have any questions regarding our transition, our Quality Assurance and Regulatory Affairs representative, Henry Davies, is here to help. Get in touch here!
If you have any questions about ordering or your account, our team are on hand to help you, via phone (+44 1280 702002) or e-mail (firstname.lastname@example.org).
The highlighted information was added later, on Wednesday 9th November 2022.