We regret to inform you that from the 1st June 2021 we will no longer be offering artificial eyes and cosmetic shells. We apologise for the short notice and the immediate decision that had to be made.
Our regulatory advisors have recently informed us that artificial eyes and cosmetic shells will need to comply with the new Medical Device Regulation (MDR), the cost to complete the necessary requirements are too great for us to consider which has led to the removal of artificial eyes and cosmetic shells from our portfolio.
We can recommend Ocellus Laboratory (https://www.dencott.com/fr/prothese_oculaire.html) in France as an alternative supplier or if you would prefer, you can visit this website (https://ocularist.org/) to find a manufacturer close to you.
For our SFX customers, we know the MDR will not affect your products directly but as our sister company produced artificial eyes and cosmetic shells for human use, the SFX side is a casualty of circumstance. We had to make a decision that was heavily affected by the downturn of orders along with the cost of MDR compliance and running the Hemel Hempstead site.
As they were not able to gain MDR accreditation, we had to stop manufacturing from their factory immediately.