Endotine CE Mark Delayed

I’m sorry I can’t bring good news about the availability of Endotine in the UK and in fact throughout all of Europe.

I have just received the following from MicroAire Surgical Instruments; manufacturer of the Endotine range.

“MicroAire’s notified body for Europe (BSI) has declined to renew the Endotine CE Mark under the current EU Medical Device Directive (MDD).

 This means that MicroAire must now begin anew, and apply for the Endotine CE Mark under the forthcoming EU Medical Device Regulation (MDR).  The new regulation is much more complicated and there is already a lengthy queue for approvals at BSI. Therefore, Endotine will continue to be unavailable for a long time, perhaps throughout all of 2020 and into 2021.

 We are looking for any path to accelerate this timeline, while complying with all regulations, but it appears that our options are limited.

 Please note that the issues preventing re-certification are administrative only, and they are unrelated to Endotine’s performance and safety, both of which are strong.”

Once again; I’m sorry it isnt better news.

Ben