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BIVDA’s Regulatory Affairs Seminar 2023 Summary

By October 6, 2023No Comments

The annual Regulatory Affairs Seminar was held this week in Edinburgh at the Balmoral Hotel. Day 1 opened with the industry webinar hosted by the MHRA on Innovative Devices Access Pathway. This gave the attendees access to a scheduled webinar which occurred at the same time as our opening session by BIVDA so they didn’t miss out. This was followed by an update from Iana Slobodeaniuc, MedTech Europe. Iana provided valuable insights on the current status and challenges of the IVDR. BIVDA has a long and established relationship with MedTech Europe and has supported the seminar for many years and with BIVDA being the only UK representative National Association for IVD in Europe, it is great to continue working together to give our members the opportunity to discuss IVDR.

The follow-on sessions focused on the mechanisms, challenges and best practises on importing/exporting IVDs from the UK to global regions by Eamon Doherty, Oxford Immunotec. This highlighted the additional challenges of moving devices across borders with additional environmental and Animal Origin regulatory requirements. Day 1 concluded with a series of workshop sessions on preparing and conducting virtual and hybrid audits by Erica Conway, MCRA, and EU technical documentation by Liz Harrison, BSI. As a working group, it is important that we share experiences and insights for the practical implementation of quality and regulatory processes. This afternoon session prompted great discussions and some key learning points for consideration.

Day 2 was more centred around the UK specific regulation of IVDs. Tom Beale, Agilent Technologies, our Chair of the UKCA subgroup provided some great context around the state of play of UKCA, and the work that the sub group have been doing, followed by a session on IVDR Northern Ireland by Jude O’Donnell, Qserve Group. We also had the pleasure of Joseph Burt, MHRA, (pictured with Helen) discussing the new Post Market Surveillance Statutory Instrument. It was great to have the involvement of MHRA at the event, to help us understand the nuances of the recent updates. An alternative legal view was provided by Alison Dennis, Taylor Wessing, on the interpretation of UKCA and future legal requirements. These sessions offered a rounded and considered perspective for our members.

Day 2 concluded with an update on international regulatory updates from Tehelj, BIVDA’s Regulatory Affairs Officer, followed by Innes Connor, Health Facilities Scotland on the role of Scotland’s Incident Reporting & Investigation Centre (IRIC). This provided some useful insights on how IRIC fits into the overall UK landscape.

The event was sold out early this year with some familiar faces in attendance. It was also really pleasing to see so many new faces who I hope received a warm and supportive welcome from the team, including BIVDA’s new interim CEO Helen Dent, who attended this seminar for the first time and I feel immensely proud to have chaired the event and, with so much uncertainty and change within the regulatory environment, have the ability to have such a positive and collaborative space for regulatory professionals from the industry, notified bodies, MHRA and other stakeholders really demonstrate the value of the BIVDA membership.


Ben Kemp