The Association of British Healthcare Institutes (ABHI) Regulatory Affairs conference was held in London last month, the first time in three years that the ABHI conference was able to be held in person.
One of our Regulatory Affairs Specialists, Samantha Watkins, attended the conference, keen to hear the latest insights from the industry and to network with industry peers.
Here is Sam’s experience in her own words…
Last month I had the opportunity to travel to London for the annual Association of British Healthcare Institutes (ABHI) Regulatory Affairs conference where I was able to network with other RA professionals and discuss the current state of the EU and UK medical device markets.
There were a number of speakers and question panels which highlighted the unique opportunity within the UK market post Brexit to increase innovation, and the challenges facing the industry with the implantation of the EU MDR.
Key discussions focused on successful strategies the MHRA could adopt from other markets and the potential impacts to patient safety due to the increased regulatory pressure, cost, and complexity. The other main topic was the availability of approved bodies to fulfil the conformity assessment requirements and the effect it could have on the medical device industry.
• 1 in 5 devices are expected to be removed from the UK market within 5 years.
• >85% of 500,000 devices that still have not transitioned from the MDD to the MDR.
• Approximately 200 UKCA certificates have been issued from the 24,000 MDD certificates.
The day was very insightful and demonstrated the desire of manufacturers to ensure that safe and effective devices are made available to patients, and that government input and guidance is desperately required to ensure patient safety during this period of challenging regulatory change.
It highlighted the advantageous position and key opportunities available to Pennine, having achieved both the UKCA and MDR certification.
If you would like to find out more about Pennine’s UKCA and MDR certification, or would like to speak to a member of our team, please contact us at firstname.lastname@example.org.