Firstly, I would like to apologies in the delay in obtaining Susol over the past Months.
I regret to say that more difficulties have arisen in relation to the move from MDD to MDR regulations in which more delays will impact in receiving Susol instruments forecasted until Q4 of 2024.
The approvals process has proven to be intricate, challenging, costly and extremely time consuming as more Data for Technical Files and rigorous Clinical trials and Evaluations now required for the Medical Device Regulations (MDR) for Sterile instruments.
This is not unique to Bailey Instruments but has impacted many other manufacturers and notified bodies within the industry.
Unfortunately, this leaves us in the position where we are unable to obtain any Susol instruments.
Any orders received to date will be cancelled with immediate effect.
I would like to add that this is not the news we expected to receive for the 2024 period and sincerely apologise for any inconvenience caused.
Should the issue be resolved quicker than anticipated, we will touch base to let you know.
The Orthorest Team