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The 2022 Regulatory Roundup

By December 16, 2022December 19th, 2022No Comments

It’s fair to say that 2022 has been a very intense year for regulatory affairs, with some key milestones along the way.

Back in January we got the much-needed transitional arrangement amendment to the IVDR, granting some extra time for a lot of products to gain full compliance. This is also the time that 6 notified bodies were added to NANDO as designated under the IVDR, and the work between DHSC and BIVDA on the Coronavirus Test Device Approval (CTDA) process continued.

Moving into Spring, a 7th notified body was designated under the IVDR, we reached the IVDR date of application, and MHRA published their response to the UKCA consultation process that ran from September to November 2021. Switzerland introduced their national legislation implementing the requirements of the IVDR for the Swiss market, and the need for a Swiss Authorised Representative (CH-AR).

Summer brought a quieter period for the industry, but also introduced Stuart Angell as the new chair of the BIVDA Regulatory Affairs Working Party; what a great job, so far!

Things have been ramping back up over the past few months, with confirmation of a 12-month extension to the UKCA standstill period, the newly published update to ISO 15189, and the reignition of the BIVDA UKCA sub-group.

We held our annual Regulatory Seminar in October with fantastic discussion and knowledge shared throughout – even during the evening meal and quiz!

Registration is now open through Eventbrite for 2023 events.

Upcoming 2023 Regulatory Affairs and UKCA working party dates:

  • UKCA: 22 February
  • RAWP: 28 March (1-day Regulatory Affairs Seminar)
  • UKCA: 18 April
  • RAWP: 14 June
  • UKCA: 13 July
  • UKCA: 8 September
  • RAWP: 3-4 October (2-day Regulatory Affairs Seminar)
  • UKCA: 28 November
  • RAWP: 15 December

The BIVDA team hopes you all have an amazing festive break, and thank you all so much for your incredibly contributions throughout 2022!

Ben Kemp