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Ben Kemp

Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA’s blended Regulatory Affairs WP Meeting attracts fantastic attendance

On 1 July, the Regulatory Affairs Working Party met during a blended meeting to consider and learn about the enormous shifts in IVD regulation taking place. Over 100 attendees joined online or in-person, making it a record attendance in the group's history. On the agenda were developments such as the newly published MHRA consultation responses on the UK medical devices…
Ben Kemp
July 1, 2022
HighlightsHighlights Archive

Northern Ireland Protocol Bill passes first reading stage despite strong criticism

On Monday, Prime Minister Boris Johnson secured a 74-vote majority on the Northern Ireland Protocol Bill to shred post-Brexit trade rules relating to the area. Despite winning the vote, there were a number of senior Conservatives speaking out against the legislation, although none voted against it. Leading criticism of the Bill was former PM Theresa May who warned of reputational…
Ben Kemp
July 1, 2022
HighlightsHighlights Archive

Media Monitoring: 25th June – 1st July

People with advanced bowel cancer are less likely to have participated in cancer screenings A collaboration between a team at King’s College London led by Peter Sasieni and a QMUL-based group led by Stephen Duffy collected data from over 14,000 people with bowel cancer and over 29,000 people who did not have bowel cancer They estimated that the risk of…
Ben Kemp
July 1, 2022
HighlightsHighlights Archive

100,000 free copies of BS ISO 50005:2021 available in Net Zero push – download yours here!

100,000 copies of BS ISO 50005 are being sponsored by the Department for Business, Energy and Industrial Strategy (BEIS) as part of their commitment to support small and medium-sized organizations to manage their energy performance and help the UK to meet Net Zero. The standard provides organisations with a means to develop a practical, low-cost approach to energy management. Using…
Ben Kemp
July 1, 2022
HighlightsHighlights Archive

Medicinal Products Working Group, Technical Barriers to Trade Specialised Committee and the UK-EU TCA updates

Medicinal Products Working Group and Technical Barriers to Trade Specialised Committee update and call for any issues related to the UK-EU TCA: The Medicines and Devices (Goods) team remain ready to stand up the Medicinal Products Working Group (MPWG) and continue working to progress the forum. They have agreed a pragmatic compromise with the Commission that the Technical Barriers to…
Ben Kemp
July 1, 2022
Membership NewsMembership News Archive

CTDA Update

Recognising that a significant amount of the discussion is commercial and in confidence, we are able to share with members some positive outcomes. Firstly, there is recognition that the questions from the webinar have not yet been answered, they have confirmed that all the operational questions are answered internally and they are waiting for a couple more responses back from…
Ben Kemp
July 1, 2022
Membership NewsMembership News Archive

BIVDA contributes to industry panel at the MediWales Connects conference 2022

MediWales Connects was held on 29 June in Cardiff, with fantastic turn out from industry and the healthcare sector. Sessions covered the changes taking place within NHS Wales and talks from key stakeholders on important updates for the sector. Ashleigh spoke on the topic of IVD Regulation and how this is likely to impact stakeholders, including providing some detail on…
Ben Kemp
July 1, 2022
Membership NewsMembership News Archive

MHRA has published their response to the ‘future regulation of medical devices in the UK’ consultation

On 26 June, MHRA published their formal response to the consultation on the future regulation of medical devices in the United Kingdom. This has been eagerly anticipated and gives a lot of detail on what can be expected for the new regulatory framework. The document totals 155 pages and has 16 chapters. An executive summary drafted by BIVDA can be…
Ben Kemp
July 1, 2022
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