Membership News

It is with great pleasure that I introduce myself to you after joining BIVDA on the 15th November as Policy Officer. I have been looking forward to it and am delighted they appointed me to join their team. My first week has been filled with many exciting challenges and I am very fortunate to have been expertly guided by new…

The BIVDA Madden Room will soon be upgraded to include a high-performance AV/VC suite which will be available to members to book and use as well as enable BIVDA to host our working party meetings in a blended manner. Over the past months, we have been communicating our future approach to meetings to members that we intend to adopt a…

Yesterday marked the start of World Antimicrobial Awareness Week (18-24 November 2021). BIVDA, as well as having an AMR working party, also is part of the AMR Diagnostic Programme Board (with BIVDA represented by Doris-Ann) and on the Longitude Prize Panel (again represented by Doris-Ann). We are also members of the AMR Industry Alliance which is a global initiative run…

A new 'UK Responsible Person Directory' page will be launched on 1 December by BIVDA, with support from member company IVDeology. The directory will be of use to those looking to have their UKRP status made known to those looking to place a devices on the UK market. The UKRP Directory is available free of charge to BIVDA member companies…

The Medical Devices and Clinical Consumables Contingency Planning Group at the Department for Health and Social Care have provided the summary information below. This is regarding border controls for importing products from the EU into GB from 1 January 2022. Key Changes from 1 January 2022 From 1 January 2022, full customs declarations for imports will be required and the…

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…

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.…

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…

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…