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Regulatory Affairs Working Party

BIVDA involvement with ongoing MHRA regulatory work Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA involvement with ongoing MHRA regulatory work

BIVDA takes part in the monthly MHRA/Trade Association meeting which allows for open dialogue between everyone involved. Recently, this has been focussed on the ongoing regulatory changes in the UK. This meeting is BIVDA’s opportunity to raise any concerns from members and get key insight into the regulatory changes in the UK. The last meeting was on 2 December, providing…
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December 9, 2021
European Council confirms they will not amend IVDR delay proposal Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

European Council confirms they will not amend IVDR delay proposal

On 1st December, the European Council confirmed that they have agreed to proceed with an accelerated legislative procedure for the proposed delay of the EU IVDR. This means they will not be suggesting any changes to the text included with the proposal in order for it to progress through legislation more quickly than would typically take. This proposal pushes back…
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December 3, 2021
Consultation on specific IVD related GMDN terms Consultations ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Consultation on specific IVD related GMDN terms

The GMDN Agency have provided the summary information below. This is regarding a consultation on specific IVD related GMDN terms. The IVD Team at the GMDN Agency have launched a consultation regarding a proposed scaling back of antibody-specific IVD terms within the GMDN. The move would be to consolidate all infectious disease antibody-class specific terms for a particular analyte to…
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November 19, 2021
Regulatory Discussions Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Discussions

I’d like to thank members for sending me questions and concerns relating to IVD regulations. This has spanned a wider remit than I initially expected it to, but the key topics that seem to be coming up time and time again are the concerns with MHRA registrations (which Doris-Ann spoke about in last week’s newsletter), and the transitional concerns relating…
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November 12, 2021
Regulatory Affairs information on product registrations with MHRA Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs information on product registrations with MHRA

As you all know, all general IVDs have to be registered with MHRA by 31st December. We have recently had a number of issues about delays to registration raised by members, frustrated by lack of response from MHRA to email queries. Doris-Ann raised this as an agenda item for the MHRA Liaison meeting yesterday. MHRA’s response was that they are…
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November 5, 2021
Regulatory Affairs Seminar 11 – 13 October 2021 Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs Seminar 11 – 13 October 2021

This year’s RAWP Seminar has taken place this week face to face in the wonderful city of Liverpool. Members were able to access key speakers from MedTech Europe and MHRA discussing a wealth of key IVD Regulatory related topics including IVDR timelines, UKCA implementation updates and discussions, new MHRA UK Legislation discussions, DEFRA, HSE and impact analysis.  They were also…
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October 14, 2021
BIVDA Regulatory Affairs Seminar 2021 Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA Regulatory Affairs Seminar 2021

This years' seminar will be held at the Liverpool Marriott Hotel City Centre.  Draft Agenda We are currently in the process of finalising bookings for next months' seminar with the hotel. We would request that any members who have yet to book to contact Natalie ASAP or register through the link below. BIVDA Regulatory Affairs Seminar 2021 Tickets, Tue 12…
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August 10, 2021