In brief
Medical device companies anticipating new rules post-Brexit may be feeling somewhat overlooked to hear the BEISs recent announcement regarding UKCA marking. From this announcement, it transpired that the UKCA marking announcement did not include medical devices and in-vitro medical devices.
The BEISs original and a seemingly blanket statement that the “Government is making it simpler for businesses to apply new product safety markings” was subsequently revised so as to specify that: “Medical Devices (including IVDs) continue to be subject to different UKCA rules with the MHRA consultation on UKCA and the DHSC response to this expected to be published in due course.”
The MHRA responded on the back of the BEISs announcement, acknowledging that BEIS easements will not apply to HealthTech, but that transitional arrangements for HealthTech will be published shortly. These arrangements, the MHRA specified, will differ to those implemented for other ‘new approach’ goods in that they will allow manufacturers time to observe new medical device regulatory requirements.
Whilst the MHRA acknowledged Trade Association members’ concerns regarding the uncertainty of how HealthTech products will be marked, the anticipated content of the MHRA’s response to CA marking consultation remains uncertain.
For further information, please contact Julia Gillert of our London office.
