What is the In Vitro Diagnostic Regulation?
The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices. Entering into force on the 25 May 2017 marking the start of a five-year transition period for manufacturers and economic operators, the IVDR replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC.
Manufacturers wishing to apply to a notified body for a conformity assessment of their IVD medical device have until the Date of Application of the IVDR in May 2022 to update their Technical Documentation to meet the requirements and comply with the new, more stringent Regulation.
BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme. The expertise of our IVD team means we are able to review devices covering over 80 NBOG codes. Our IVD specialists are product experts in their respective fields and have undergone rigorous regulatory training.