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BIVDA Member Biofortuna doubles their manufacturing capacity

Biofortuna (Deeside UK), a specialist contract development and manufacturing partner to the IVD and point of care testing sectors, has more than doubled its manufacturing capacity following its relocation to new state-of-the-art facilities in Deeside, North Wales. The purpose-built facilities have been designed by the Company to provide the most efficient and modern manufacturing laboratories from which to meet the…
Ben Kemp
November 11, 2021
Membership NewsMembership News Archive

SGS to Host ISO 13485:2016 Webinar for IVD Medical Device Manufacturers

SGS are conducting a webinar on 23 November, titled as below: ISO 13485:2016 The Journey to Regulatory Compliance for IVD Medical Device Manufacturers Webinar With the significant regulatory changes underway for market access to the EU, IVD medical device manufacturers need to be aware that the compliance requirements that they face for the new EU IVD Regulation are changing dramatically.…
Ben Kemp
November 11, 2021
Membership NewsMembership News Archive

BIVDA applies for membership of the UK Domestic Advisory Group

The UK-EU Trade and Cooperation Agreement (TCA/the Agreement) provides for the involvement of civil society through the creation of a Domestic Advisory Group (DAG) and Civil Society Forum (CSF) in advising on the implementation of the Agreement. The Government sees the DAG as an important consultative body which will enable it to hear from those most affected by the operation…
Ben Kemp
November 11, 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
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 ArchiveMembership NewsMembership News Archive

BIVDA Celebrates Doris-Ann’s 20-Year Anniversary

BIVDA Celebrate Doris-Ann Williams 20 year Anniversary On 1 October 2021, Doris-Ann Williams celebrated her 20-year anniversary of joining BIVDA to lead and develop the trade organisation which represents the In Vitro Diagnostic industry in the UK. The landscape for IVD’s is unrecognisable and the achievements realised by everyone in the industry are countless, it is clear that Doris-Ann has…
admin
October 6, 2021
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