With the post-Brexit environment now being a reality for the UK Life Science industry, many medical device manufacturers will be devoting resources in a concerted effort to comply with the pending new EU Medical Device Regulations (MDR) and the new In Vitro Diagnostic Regulations (IVDR).
However, the focus of this effort should not overlook the new UK replacement of the CE mark, the United Kingdom Conformity Assessment (UKCA).
At the time of writing, the MDR regulations shall become an enforceable regulatory requirement in a matter of days, with the IVDR being implemented in just over a year. This article serves as a reminder to medical device manufacturers and a heads-up of the pending UKCA mark, which will become an enforceable regulatory requirement on the 30th of June 2023.
As the UKCA mark can be used voluntarily until the 30th June 2023 deadline, Zener Engineering Services (ZES) recommends that medical device manufacturers begin working towards achieving the UKCA certification. From the 1st of July 2023, a medical device will require a UKCA mark to be in place, in order for the medical device to be sold in the UK.
The main reason ZES recommends that medical device manufacturers start their journey towards achieving the UKCA mark now, is simply the anticipated delay in approvals from the new UK Approved Bodies, of which, at the time of writing, there are currently three.
Between now and the 30th June 2023 UKCA implementation date, and in line with other regulatory updates, ZES expects more official guidance to be issued from the MHRA. However, ZES already know the majority of the potential common pitfalls. Experts from ZES can expertly advise on how to meet the requirements of the new regulations.
ZES director David Easton said: “Medical device manufacturers should take advantage of the UKCA implementation transition period and utilise our expert services.
“With the deadline for registering high-risk medical devices now past, now is the time to consider the updated more stringent regulatory requirements such as those applying to data protection.”
