The Proposal for New IVD Regulation
The European Commission’s Proposal for a Regulation on in vitro diagnostic medical devices (IVDs), an update on Directive 98/79/EC, takes into account the changes that have occurred both in terms of market demands and technological innovation over the last decade or more. The basic premise and priority of the legislation remains as it was – to ensure IVDs are safe and effective, and aspects that have changed are related to the need for regulatory measures for IVD-related software, companion diagnostics, point-of-care testing and genetic testing. These include adoption of classification grades in line with GHTF and changes to the conformity assessment.
For more information on Directive 98/79/EC or the new proposal for legislation, READ MORE.