European Diagnostic Clusters Alliance declares position on new European directive for in vitro diagnostic products

By Biocat

The European Diagnostic Clusters Alliance (EDCA), of which Biocat is a member, has published a paper analyzing the European Commission’s proposal for a new Regulation on in vitro diagnostic medical devices (IVD), which must be approved by the European Parliament in order to go into force in 2015. The EDCA’s assessment is positive overall, pointing out that the new regulation strikes a good balance between patient safety and the EU’s necessary commitment to innovation. However it also asks that the Parliament improve aspects like the definition of companion diagnostics, access to biological materials and labeling and traceability of IVD devices.

This position paper by the EDCA is the result of enquires made by its members in each of the clusters that belong to the Alliance after the new regulation was approved in late 2012. They have a positive view of, among other aspects, the fact that the new regulation addresses the obligations of not only manufacturers but also economic operators in the sector, like distributors; that it incorporates a description of good clinical practices for the assessment of IVD medical devices; that it standardizes product identification using the UDI system (Universal Device Identifier); and that it includes a clear definition of the information the EU Declaration of Conformity must contain.

The aspects that need improvement include a single model to transport and store clinical information associated with IVD, with smart use of the options offered by cloud computing; an intermediary market for innovative IVD devices; and a specific assessment of the impact of this new regulation on SMEs and that they be given the necessary flexibility to compete in this market.

The EDCA is currently made up of ten members, after approval of Medicen (Paris region, France) at the meeting held on 5 June in Germany under the framework of the fifth Berlin-Brandenburg Technology forum. The other members, in addition to Biocat, are Euromediag (Languedoc-Roussillon and Provence-Alpes-Côte d’Azur, France), BioWin (Wallonia, Belgium), Life Science Cluster Krakow (Krakow, Poland), Lyonbiopôle (Rhône-Alpes, France), Oxfordshire Biotech Network (Oxford, United Kingdom), Uppsala BIO (Sweden), Welsh Government Life Sciences Team (Wales, United Kingdom) and ZMDB (Berlin-Brandenburg, Germany).

Each member of the EDCA represents a European cluster with significant critical mass in the medical diagnostics field, both in science and industry. There are a total of approximately 350 companies and 46 universities. In Catalonia there are roughly 30 SMEs and 50 research groups associated with this activity.

At the meeting in June, members also approved Biocat to take over the secretariat general of the EDCA, represented by head of Entrepreneurship and Business Growth Carlos Lurigados. Lurigados takes over for Bruce Savage of OBN. The president of the Alliance is Frank Molina of Euromediag and the treasurer is Thierry Leclipteux of BioWin.

EDCA participates in EIC 2013 in Montpellier

EDCA members will meet again at the third Euromediag International Convention (EIC 2013), held by Euromediag on 25 and 26 September in Montpellier. This convention brings together the main European stakeholders in biomedical research for diagnostics, from both industry and research centers, with the aim of seeking out new paths and alliances to move forward on personalized medicine. The Transbio Forum will also be held on the same date and in the same city, with Biocat and a good number of companies and research centers from Catalonia. More information on this event will be available on this site shortly.

For more information, see the EDCA position paper or contact:
Biocat
Business Development Department
Carlos Lurigados
clurigados@biocat.cat

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