BSI was informed on 26 October 2019 by the Medicines and Healthcare products and Regulatory Agency (MHRA) that its UK notified body is one of the first in Europe to be designated to the new IVDR (EU 2017/746).
BSI is also the first notified body to achieve full scope designation, which covers all devices specified under the Implementing Regulation (EU) 2017/2185 for IVDR. This includes several new categories of devices with specific characteristics that were not covered by the In Vitro Diagnostics Directive such as cancer tests, genetic tests, physiological markers, and companion diagnostics.
The IVDR was published on 5 May 2017 and manufacturers will need to start complying with it by May 2022 in order to be able to place their devices on the market within the European Economic Area. The challenge, until very recently, has been that no notified body was approved to undertake conformity assessments under the new, more stringent, legislation.
Under the existing In Vitro Diagnostics Directive (98/79/EC) legislation, the majority of IVD devices did not need to be independently assessed by a notified body as a manufacturer could self-declare conformity. With the incoming regulation, the majority of IVD products will have to be independently assessed by a notified body.
BSI will now be able to provide conformity assessments to the full scope of the IVDR which includes over 80 codes. For further details on BSI’s scope, please visit the NANDO information system.
Manuela Gazzard, Group Director of Regulatory Services at BSI commented: “We are very proud to be one of the first to achieve IVDR designation in the UK – and the first notified body to achieve full scope designation. To ensure we have capacity to meet market demand, we’ve been expanding and training our people to be able to deliver IVDR conformity assessments.”
Gary Slack, Senior Vice-President of the notified body at BSI, said: “The IVDR industry is undergoing some dramatic changes as the number of products requiring notified body assessment moves from approximately 20% to at least 80%. With capacity issues being a concern, this designation will help alleviate this as manufacturers start the process to transition to the IVDR.”
Manuela concludes: “Being the first to achieve full scope designation to the Medical Devices Regulation and now one of the first for In Vitro Diagnostics Regulation is testament to the hard work, dedication, skills and expertise of our people.”