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UKCA

BIVDA UKCA sub-group 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
MHRA to extend UKCA date of application by 12 months Membership NewsMembership News Archive

MHRA to extend UKCA date of application by 12 months

MHRA have distributed a letter to industry and the Devolved Administrations in relation to the date of application of the new UKCA regulatory regime. The letter confirms that the date of application will be extended by 12 months until July 2024. This means that there will continue to be unilateral recognition of the CE mark until this date, and CE…
Ben Kemp
October 21, 2022
Webinar – The New UK Regime for Goods: MHRA/BEIS: Medical Devices Membership NewsMembership News Archive

Webinar – The New UK Regime for Goods: MHRA/BEIS: Medical Devices

BEIS are putting on a number of webinars to help companies better understand the UKCA regime. This week they announced a special webinar exclusively focused on the regulatory framework relating to UKCA marking for medical devices on Thursday 6 October 2022 at 15:00 – 15:40. This should help businesses to get ready for the new regime as soon as possible…
Ben Kemp
September 2, 2022
BIVDA discusses upcoming UKCA Regulations on newly-released MedTalk Podcast episode 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
UKCA Regulation update and request for EU certification data 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
MHRA request for possible repercussions of UKCA Regulations Membership NewsMembership News Archive

MHRA request for possible repercussions of UKCA Regulations

Doris-Ann, Ashleigh and the Chairs of the Regulatory Affairs Working Party met with the senior leadership of MHRA on 1 April. The aim of the meeting was to discuss the ongoing changes affecting the IVD industry, such as the changes to the structure of MHRA and the upcoming UKCA Regulations. MHRA provided reassurance that they are trying to move as…
Ben Kemp
April 8, 2022