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Membership NewsMembership News Archive

BIVDA reacts to the IVDR legislation coming into effect on Thursday

Thursday marked the date of application of the in vitro diagnostic regulation. This regulation applies to IVDs placed on the market in the European Union and Northern Ireland, bringing with it a heightened regulatory regime. BIVDA have released a full press release to celebrate this new chapter of IVD regulation. Please see the text below: BIVDA welcomes the In Vitro…
Natalie Creaney
May 27, 2022
Membership NewsMembership News Archive

New paper highlights overlap in EU and US requirements to support efficient compliance

Members may find this white paper useful in ascertaining EU IVDR clinical evidence requirements and how manufacturers can efficiently comply. It is imperative that manufacturers do not underestimate the time required to source the right clinical evidence for their products. As the risk to individual and public health increases with each device classification under the IVDR, the corresponding conformity assessment…
Ben Kemp
April 8, 2022