Regulatory Affairs Manager Ashleigh Batchen has compiled a comprehensive response to the WEEE Compliance Fee Methodology 2022 consultation. The consultation response can be read here.
Natalie CreaneyNovember 18, 2022
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 KempNovember 3, 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 CreaneyOctober 21, 2022
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 KempOctober 14, 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 KempOctober 7, 2022
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 CreaneySeptember 16, 2022
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 KempSeptember 2, 2022
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 CreaneyAugust 19, 2022
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 CreaneyAugust 5, 2022
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 KempJuly 1, 2022