The amending regulation which extends the transitional provisions of the IVD Regulation has become EU law and comes into force from today. This is immediately applicable in all member states, and will allow for further preparation time for companies depending on device classification.Regulation (EU) 2022/112 extends the IVDR transitional periods, allowing most devices with their EC Declaration of Conformity under the IVD Directive to be placed on the market and or put into service for an additio...

A North East-based lab is celebrating one year since it was set up to accelerate the development of the next generation of virus testing

A new product developed between Bedford-based Life Science Group Ltd (LSG) and Coventry University has the potential to transform the delivery of cell and gene therapy and in the longer term make these cutting-edge, personalised treatments more accessible

The European IVD Market Statistics Report 2021 has just been published by MedTech Europe. The latest version of this annual report shows that revenues for IVDs increased by an unprecedented 25.4% across the EU27 member states (plus EFTA, the UK and Turkey) between 2019 and 2020. Most of this increase was due to COVID-19 related diagnostics, however there were significant increases in specific tests, and dramatic decreases in others which varied from country to country. For UK-specific data compa...

Please see the below press release which outlines the facts regarding the UK's capacity to manufacture lateral flow tests

For Immediate Release --BIVDA, the UK’s national association for the manufacturers and distributors of in vitro (IVD) products, welcomes the adoption of amended transitional provisions of the In Vitro Diagnostic Medical Devices Regulation.This decision will allow for a more workable transition for IVD sector companies to prepare for transition into the new European regulatory framework for IVD medical tests.On 20th December, the European Council confirmed their support in full of the propo...

A new clinical validation study from Oulu University Hospital was recently published in a widespread international cancer journal, confirming that new-generation GastroPanel® test is highly accurate in diagnosing atrophic gastritis and Helicobacter pylori infection in gastroscopy referral patients

Life Science Group (LSG) has been shortlisted for a prestigious award which recognises and promotes the excellence that East and West Midlands companies are achieving at the leading edge of the Life Sciences sector

Semi-Quantitative COVID-19 IgG Antibody Rapid Test now available for use by professionals or trained lay-users

The European Stakeholder Group has issued a joint statement calling for clarity on the United Kingdom’s association to Horizon Europe as soon as possible. A formalisation of the UK's involvement and access to the Horizon Europe programme has not yet taken place following the UK's departure from the European Union.Horizon Europe is the EU’s key funding programme for research and innovation with a budget of €95.5 billion. It creates jobs, fully engages the EU’s talen...