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UKCA Regulation update and request for EU certification data

By August 5, 2022No Comments

Doris-Ann and Ashleigh attended the latest MHRA Trade Association Liaison meeting on 4 August.

This meeting provided some much-needed updates regarding the UKCA Regulation and the delay to the Focus Groups starting (which were initially intended to start in March).

The Regulations are being drafted by the MHRA legal team, and it is hoped that these will be released in the Winter. Once published, there will be a 6-month window before they can come into force. Alongside this work, guidance is in development for these regulations. Once some of this guidance has been drafted, the Focus Groups will start with the aim of reviewing this draft guidance and providing feedback on any changes that may be required; the newest date for these Focus Groups to begin is October. BIVDA will be involved in these Focus Groups.

MHRA have confirmed these are intended to be managed similarly to how they were previously planned, and trade associations may still be able to bring key representatives from within their membership. This is likely to be limited to one or two individuals.

Trade associations at the meeting, including BIVDA, reiterated that clear, published timelines would be hugely welcomed to allow industry sight of what is to come.

As well as this, MHRA have requested feedback from industry on possible gaps in certifications between the MDD/IVDD and the MDR/IVDR, and information on the volume of organisations progressing through conformity assessments.

If your organisation has experienced a gap between expiry of your MDD/IVDD certification and gaining certification under the MDR/IVDR, please let Ashleigh know as soon as possible (i.e. if there has been a period where your product has not had valid certification). Alternatively, if you feel there is a serious risk of this happening to your organisation, please inform Ashleigh. MHRA are trying to understand the scale of this issue and if it could result in product shortages.

Members are also requested to confirm with Ashleigh if you have products currently going through conformity assessment under either the MDR or IVDR – please clarify which regulation is appropriate for your products.

All information will be anonymised before being provided to MHRA and will likely be in numerical form only.


Natalie Creaney