Category

Regulatory Affairs Working Party Archive

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
Regulatory Affairs Working Party Seminar 2022 Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs Working Party Seminar 2022

On 13 and 14 October, we held our annual Regulatory Affairs Working Party Seminar. This went very well (it wouldn’t be an event without some slight technical issues), with a fantastic turn out. BIVDA would like to thank all of our speakers, the Regulatory Affairs Working Party team, and all of the attendees for making it such a positive event.…
Natalie Creaney
October 21, 2022
France Biotech & Eucope Regulatory Survey Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

France Biotech & Eucope Regulatory Survey

France Biotech is conducting a field survey with Eucope. This survey is intended to highlight the difficulties encountered by small and medium-sized companies of Medtech sector to comply with the clinical and regulatory requirements of the MDR. They require more foreign respondents to ensure a significant European representativeness, with a deadline of 11 November 2022. The survey can be accessed…
Ben Kemp
October 14, 2022
Regulatory Affairs Working Party Seminar 2022 Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs Working Party Seminar 2022

Next week brings our annual Regulatory Affairs Working Party Seminar, taking place on 13 and 14 October at The Belfry in Birmingham. This event will immediately follow from our joint working party event on the 12 October. Please find the full agenda for the event here. The dress code for the overall seminar is smart-casual. There will also be a…
Ben Kemp
October 7, 2022
Limited places remaining for the Regulatory Affairs Working Party Seminar Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Limited places remaining for the Regulatory Affairs Working Party Seminar

Our annual Regulatory Affairs Working Party Seminar is planned for 13-14 October, and is fast approaching. This event is now almost sold out. Members are encouraged to book as soon as possible if you are interested in attending to prevent disappointment. The latest agenda can be found here. Please note that there are now only rooms available at The Belfry…
Natalie Creaney
September 16, 2022
Update: Declaring reusable packaging for Great Britain imports and exports Export Working PartyExport Working Party ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Update: Declaring reusable packaging for Great Britain imports and exports

When to submit a safety and security declaration for imports into Great Britain has changed. No new import controls will be introduced in 2022. A new target operating model of border controls will be published in Autumn 2022, with an aim to introduce the new rules by the end of 2023. The full guidance document can be accessed here.
Ben Kemp
September 2, 2022
MHRA to change method of reporting adverse events Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

MHRA to change method of reporting adverse events

On 18 August, MHRA held a webinar to explain what changes are coming in how adverse events vigilance reports should be submitted. The current MORE reporting system is being updated to a new MORE system. This means that adverse event reports must be submitted using this new system from November 2022 or via MHRA’s custom API for direct submission through…
Natalie Creaney
August 19, 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
BIVDA’s blended Regulatory Affairs WP Meeting attracts fantastic attendance Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA’s blended Regulatory Affairs WP Meeting attracts fantastic attendance

On 1 July, the Regulatory Affairs Working Party met during a blended meeting to consider and learn about the enormous shifts in IVD regulation taking place. Over 100 attendees joined online or in-person, making it a record attendance in the group's history. On the agenda were developments such as the newly published MHRA consultation responses on the UK medical devices…
Ben Kemp
July 1, 2022