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Latest UKCA extensions do not apply to medical devices

This includes: The General Product Safety Regulations 2005 Supply of Machinery (Safety) Regulations 2008 Electromagnetic Compatibility Regulations 2016 Pressure Equipment Safety Regulations 2016 Electrical Equipment (Safety) Regulations 2016 Simple Pressure Vessels (Safety) Regulations 2016 Radio Equipment Regulations 2017 These timelines have been extended for 12 months to allow extra time for compliance. Importantly, these timeline changes do not impact medical…
Natalie Creaney
November 18, 2022
Member RequestsMember Requests Archive

Department for Business, Energy & Industrial Strategy (BEIS) Announcement on UKCA Marking (Non-Medical Devices) – Further Webinar Dates Announced

Following on from the BEIS announcement to introduce legislation to continue recognition of the CE marking and reversed epsilon marking until 31 December 2024, a further two webinars will be held on Monday 21 November 2022 for anyone unable to attend the previous webinar session on Wednesday 16 November. Please find the registration links below to register for either of…
Natalie Creaney
November 18, 2022
Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA UKCA sub-group

BIVDA previously ran a UKCA sub-group which was an off-shoot of the Regulatory Affairs Working Party. This group hasn’t met recently due to insufficient content. Now that we have slightly more clarity on the UKCA regulations and MHRA have committed to introducing timeline legislation in Spring 2024, we thought this was the opportune time to restart this group. The UKCA…
Ben Kemp
November 3, 2022
Membership NewsMembership News Archive

BIVDA discusses upcoming UKCA Regulations on newly-released MedTalk Podcast episode

The episode has been released today, Friday 12 August, and features our Regulatory Affairs Manager, Ashleigh discussing some key messages that came out of the consultation response such as transition periods and the risks that are still remain for products on the market. The MedTalk Podcast covers topics across life sciences with a number of existing episodes touching on IVDs…
Natalie Creaney
August 12, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

UKCA Regulation update and request for EU certification data

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…
Natalie Creaney
August 5, 2022
Membership NewsMembership News Archive

Delay to UKCA consultation response

The UK Government has entered into their pre-election period, which means that they are limited on what can and cannot be discussed in relation to policy. Because of this, MHRA have confirmed that there will be a delay to publishing the response to the MHRA UKCA consultation (which closed in November), until this period is over on 9 May. The…
Ben Kemp
April 14, 2022