I recently attended a brilliantly presented BSI webinar entitled: “UKCA for Medical devices and IVDs, are you ready?” which provided additional insight and confirmation of the UKCA conformity assessment process. I also propose a heartfelt thank you to Dr. Jayanth Katta for taking his time to provide the medical device and IVD industries with guidance.

Presentation highlights:

  1. Each legal manufacturer may assign only one UKRP in the UK
  2. EU CE marked products currently on the market in the UK may remain on the market (until 30 June 2023) however, these products must be registered with the MHRA according to the classification schedule
  3. Manufacturers continuing to market CE marked product must assign a UKRP, however they do not yet need to be identified on the labelling
  4. When BSI CE0086 certificates expire (or require amendments) they will automatically convert to UKCA certifications and be subjected to UKCA legislation

Conformity Assessment

  1. Note that conformity assessment models will differ between and amongst the UKABs
  2. BSI will start accepting UKCA applications during the last week of January but please note that they are still grappling with closing out actions relating to MDD deadlines
  3. For those manufacturers lucky enough to obtain CE2797 certification may be able to gain UKCA certification via an abridged review process
  4. For those manufacturers who obtain CE marking (directive or regulation) through a non-BSI EU NB, UKCA conformity assessment will follow the principles of EC certificate transfer

New Products

  1. BSI will endeavour to execute combined CE and UKCA assessments for medical devices whenever possible. This activity, is of course, subject to a number of caveats.
  2. The decision whether to submit and maintain combined or separate technical file documentation remains with the manufacturer
  3. Inconsistent classification should not impact a potential combined assessment

Due to the significant differences between the regulatory requirements for IVDD and IVDR, it is unlikely that a combined technical file and conformity assessment would be feasible.

During this unprecedented and challenging time, medical device and IVD regulatory professionals certainly have to keep a vast number of plates spinning in order to ensure their company’s products remain compliant for marketing. Those of you with the in decision making roles, please guarantee that your Reg Ops teams are equipped with the necessary tools and resources to support their revenue generating activities.

KimYoung@instem.com

K Young

References

https://www.bsigroup.com/en-GB/medical-devices/brexit-medical-devices/