Skip to main content
search
All Posts By

admin

AMR TaskforceAMR Taskforce ArchiveConsultations Archive

UK Health Security Agency – sepsis consultation

Closing: 29/11/2021 New Consultation: UK SMI S 12: sepsis and other systemic and disseminated infections | See here BIVDA is seeking company input members of the AMR working party to respond on behalf of the sector. Please send your comments to Ashleigh no later than Wednesday 24 November COB. Please register for a Ad-Hoc AMR consultation response meeting with Doris-Ann…
admin
November 19, 2021
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…
admin
November 19, 2021
Consultations Archive

MHRA Consultation on the UK’s future medical device regulatory regime

The MHRA has launched the public consultation on the future medical devices regime, with survey responses requested from industry stakeholders. BIVDA’s Regulatory Affairs Working Party has a sub-group dedicated to UKCA matters and will be working on an industry response to the consultation. Members are advised to submit their own responses independently as a priority. The consultation closes at 11:45pm…
admin
November 16, 2021
Membership NewsMembership News Archive

Mandatory Validation of Covid-19 Tests – Industry Update

Applicants who submitted an application prior to the 31st August 2021, were expecting to continue to provide their tests to market until 31st October pending the approval by CDTA under The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (legislation.gov.uk) CDTA were unable to conclude approvals within this time frame, and whilst in some cases, the quality of applicant’s…
admin
November 5, 2021
Membership NewsMembership News Archive

MHRA consultation on new Regulations

BIVDA are in the process of formulating our response to the ongoing MHRA consultation on the new Regulatory framework for medical devices and IVDs in the UK. This will ultimately be channelled through the UKCA Working Group (initially created as an extension of the Regulatory Affairs Working Party). We fully appreciate that there may be a number of members who…
admin
November 5, 2021
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…
admin
November 5, 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…
admin
October 14, 2021
Membership NewsMembership News ArchiveUncategorized

NHS CSO’s KTP Programme

Through collaboration at a senior level with partner organisations across the UK's National Measurement System (NMS) and National Accreditation Body (UKAS), and by facilitating early interaction and knowledge exchange, the programme aims to speed up the identification and dissemination of high value new approaches to improving patient outcomes and increasing efficiency, while also promoting economic growth and inward investment in…
admin
October 13, 2021
HighlightsHighlights Archive

MDCC Webinar announced on Northern Ireland Protocol Standstill

The Medical Devices and Clinical Consumables Contingency Planning (MDCC) at the Department for Health and Social Care have announced a webinar to be held on the Northern Ireland Protocol standstill period. The event will be joined by Matthew Harpur, Deputy Director of the Goods Team at DHSC and David Simmons, Director of Supply Resilience. The Government announced on 6 September…
admin
October 8, 2021
Close Menu