OSA MDR FORUM UDPATE
The OSA held the first meeting of 2022 of its Medical Devices Regulatory Forum on 1 February. OSA consultant, Ann Blackmore, provided members with an update on how the MHRA, the medical devices regulator, is progressing work on a new regulatory regime for the UK and also explained what is being done in regard to some issues with the current regulatory system.
Ann reported that, following their consultation in the autumn of 2021 on options for a new medical devices regulation in the UK, the MHRA are now reviewing the 900 responses they had received. A written response is expected in February or March. However the MHRA is already starting work to develop the regulations and guidance that manufacturers will need for this new system to be up and running by July 2023.
The MHRA is setting up over 20 thematic focus groups to enable stakeholders to input into the development of guidance. The OSA will be joining a number of these focus groups. Members will be kept informed of the subjects under discussion and will be able to provide their thoughts and input at future meetings of the MDR forum.
Under current regulations, Ann noted that although all medical devices should now be registered with the MHRA on their new system, it is clear that there are still some problems. At the January meeting of the MHRA Trade Associations forum, which she attends on behalf of the OSA, Ann had raised concerns, on behalf of the OSA and the wider optical sector, that the registration process for those who glaze or assemble spectacles is no longer clear and that additional guidance is needed.
Ann also reported back to members that the MHRA were aware that some manufacturers had been experiencing problems at border control getting medical devices into Great Britain. In addition the Department for Business, Industry and Energy Strategy (BEIS) was aware of manufacturers having problems getting spare parts through customs.
Members are invited to let the OSA know if they are experiencing problems with medical device regulation and registration and they will be raised with the MHRA.