Working Group on Diagnostics Meets at PerMediCon

The members of the Working Group on Diagnostics used the opportunity provided by the Personalised Medicine Convention (PerMediCon), which took place in Cologne at the end of March, to discuss current topics.

The meeting opened with a presentation by a representative of the Fraunhofer Institute for Biomedical Engineering IMBT on the in vitro diagnostic medical devices platform developed by IBMT for the automation of microarrays in order to provide patients with immediate diagnoses. The working group then discussed the state of play on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices. Following the most recent discussion on the proposed regulation in a European Parliament plenary sitting at the end of October 2013, the decision was postponed. It is now scheduled for 2 April. The European Council discussed the draft in mid-December 2013, but a date for a decision by the Council has not yet been set. The experts from the working group welcomed the simplifications for small and medium-sized enterprises introduced in the draft. There was criticism of the plan to classify DNA tests in the highest risk group. The working group will follow developments on the directive on in vitro diagnostic medical devices over the course of the year and will continue dealing with the topic of companion diagnostics.

The working group plans to meet again in the second week of June and on 8 October.

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