BIVDA held our Regulatory Affairs working party on Friday 17th December.
The meeting provided an update on the ongoing and future regulatory work being conducted within the IVD sector.
This was opened by a presentation from Richard Saunders, our chair, on the European situation. Numerous guidance pages have been drafted by MedTech Europe to ease compliance to the IVDR. As well as this, the proposal to delay the implementation of the IVDR is progressing, and is likely to be published in the Official Journal of the European Union early in 2022.
A core message throughout the meeting was highlighting the possible disparities experienced throughout the sector, and the emphasis of manufacturers to ensure their products are catered for all individuals who need them.
The Government review in these disparities is being conducted in 2022, with the outcomes likely to have impacts on the whole of the healthcare industry.
Brexit has resulted in a lot of changes to the regulatory structure in the UK, with further changes in development. BIVDA has been working to ensure that members voices are heard within these proposed changes and will continue to do so.
MHRA are arranging focus groups to tackle the guidance associated with these changes, which includes a focus group for industry and trade associations. Our questionnaire on certain topics was helpful to identify the key areas of divergence for members on BIVDA’s response to the MHRA consultation.
Alongside the work being conducted by MHRA, there are major concerns over the MHRA restructuring which is taking place and how this might impact products on the UK market. Such concerns are being heard throughout industry, and BIVDA intends to reiterate these directly with MHRA.
The 2022 meetings dates are to be confirmed, but will likely be in March, June and December, with the Regulatory Affairs working party seminar in October.
Minutes and presentations will be produced shortly.