OSA Consultant attends MRHA Meeting to continue MD discussions and Sustainability issues

OSA’s consultant, Ann Blackmore, attended the MHRA’s latest monthly trade association meeting on 2 December.

The highlights of the meeting were:

Medical devices regulations consultation – the MHRA had received 891 online responses to the consultation plus a few written submissions and were now assessing them. This will enable them to refine the government’s policy and they aim to publish a response to the consultation in February 2022. Stakeholders can continue to input to this process through a series of focus groups. Introductory meetings will be set up in the next two weeks with more tailored groups planned for January. Details of when these are taking place and how to book a place are expected later this week. OSA will be represented on these groups.

A greener NHS – there was a presentation from the Department of Health and Social Care (DHSC) on the plans to achieve a net zero NHS by 2040. However the NHS also intends that NHS+ – ie the NHS plus its entire supply chain – should achieve net zero by 2045. This means that among other things, they will make changes to the medical devices they buy and how they procure them. All non-pharmaceutical suppliers will be expected to meet the NHS net zero commitment – by 2030 the NHS will not purchase from suppliers who do not do so. From April 2022 all NHS tenders will need to comply with PPN 06/20 , this mandates 10% minimum weighting on scores for tender evaluation on:

Fighting climate change
Tacking economic equality
COVID-189 recovery
Wellbeing
Equal opportunity

From April 2023, PPN 06/21will take effect. This requires all suppliers with new contracts for goods, services, and/or works with an anticipated contract value above £5 million per annum, to publish a carbon reduction plan for their direct emissions. From April 2024, the NHS will expand this requirement for all new contracts, irrespective of value.

Full details on plans for the sustainable NHS are available at https://www.england.nhs.uk/greenernhs/ including the NHS paper on Delivering a ‘Net Zero’ National Health Service. The NHS also has an open network to enable trade bodies to get involved in their work, which they are keen to expand. Details on how suppliers can get involved in this work are available here: https://www.england.nhs.uk/greenernhs/get-involved/suppliers/ The OSA plans to join the network.

Registrations with MHRA – the MHRA noted that there had been substantial system problems with MHRA registrations system. They believed that this had now been resolved but asked that if anyone was still experiencing problems making a registration to let them know.

They were also aware that there were delays in confirming registrations, but gave assurance that if someone had submitted all the correct details but not received a confirmation they would still have met their registration requirements. At past meetings questions had been raised about why some registrations had been rejected.

The MHRA had committed to compiling a list of the most common reasons for a registration to be rejected, but had not yet done this. Finally the MHRA asked TA members to let them know if any members were experiencing problems with bringing medical devices through UK customs, or if they were encountering problems due to the Northern Ireland protocol.

Members of the OSA can contact their association for further assistance if required

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