BIO Deutschland’s Working Group on Diagnostics Meets in Berlin

BIO Deutschland’s diagnostics experts met in Berlin on 8 October 2012 to discuss and evaluate the European Commission’s new proposal for a regulation on in vitro diagnostic medical devices.

The Commission presented the proposal for a regulation, which is a revision of Directive 98/79/EC on in vitro diagnostic medical devices (IVDs), at the end of September. This revision was necessary because of rapid developments in the IVD field. The Commission is using the revision to standardise conditions across the EU by introducing a regulation. Unlike the directive, which had to be implemented by EU member states and was interpreted in many different ways, the regulation applies directly in all member states.

In its proposal for a regulation, the European Commission has redrafted the classification of IVDs and adapted it to technical developments. In addition, the area of application of the proposal was defined more clearly and expanded. These changes affect:

• high-risk products manufactured and used within a single health institution;
• tests providing information about the predisposition to a medical condition or a disease and
• medical software that is explicitly mentioned in the definition of IVDs.

In addition, product labelling is to be introduced so that products can be identified and traced.

The Working Group on Diagnostics will look closely at the proposal for a regulation and observe further developments in the legislation.