Departing Regulatory Affairs Programme Lead Stuart Angell reflects on his time working as part of the BIVDA secretariat:
“I have really enjoyed my time as Regulatory Affairs Programme Lead, taking over from Ashleigh and supporting Tehelj and the wider team. As part of the role I was able to dedicate time to support the BIVDA membership and champion IVDs, and the importance of understanding the impact of IVD regulations including the EU and UK, to a much wider audience who were keen to learn more about the industry.
“I am also immensely proud of being part of the MHRA trusted advisors, doing our part as BIVDA in helping to shape the future regulation of IVDs in the UK.
“I look forward to continuing what we have started at BIVDA within my other roles as Chair of RAWP and on the executive board, but I am very much looking forward to working with closely with Neil, and the ever present support from Helen, Paul and Mike, and the rest of this wonderful BIVDA team.”
New Regulatory Affairs Manager, Neil Plumridge, who starts on 1 September, is looking forward to taking the reins, commenting:
“I intend to hit the ground running when I join BIVDA officially and have already been in discussion with Stuart and Mike regarding the ongoing tasks. I am also greatly looking forward to working with the working parties.
“In terms of the UK, our immediate priorities are the UK MDR Post Market Surveillance Statutory Instrument and then the UK MDR revision, both were imminent, but the change of government has slowed down progress as the new ministers are briefed by MHRA. Ministers will then review the proposed legislation and give MHRA their political steer on what they want MHRA to prioritise, and their desired approach to the legislation.
“Outside of this, we are likely to see continued progress with the UK government implementing Environmental, Sustainability and governance legislation, which also impacts our sector. We also have the ongoing work programmes of the HSE impacting chemicals classification and labelling and UK REACH. As the programme is based on the UK inventory, we see a divergence in priority chemicals being reviewed compared with the EU.
“Regarding Europe, I look forward to continued collaboration with MedTech Europe on sectorial legislation and the continued implementation of the EU Green Deal, alongside associated environmental and sustainability legislation.
“Globally, I will continue to monitor the output from the WHO, IMDRF and MDSAP, as well as updates to the global conventions on chemicals that are likely to impact the supply chain and/or sector: global action on PFAS substances being a good example.
“The organisation of the rescheduled Regulatory Affairs Seminar will be spearheaded by myself and I am excited to deliver an event of huge value to members filled with expert speakers from around the world.”
