Dialogue meeting on the new EU regulation (2017/746/EU) regarding in vitro diagnostics
03-09-2019 15:00 - 17:30
Mærsk Tower, room 7-15-92
2200 - København N
Biopeople & Danish Medicines Agency
The European Commission recently adopted and published the new EU regulation (2017/746/EU) regarding in vitro diagnostics (IVD), which will apply from 2022.The Clinical Trial Facilitation and Coordination Group (CTFG) and the European Commission (Directorate-General for Health and Food Safety) is collaborating in drafting guidance in this area, supporting the implementation of the new IVD legislation into the setting of Clinical Trials with medicinal products. Among such aspect are questions concerning classification, application procedures and requirements for documentation. The Danish Medicines Agency chairs the CTFG working group, which include both IVD and Clinical Trials experts.
The chair will present the progress of their work, and participants will be encouraged to debate and provide input to the various aspects. The input from this workshop will be used in the planning of an EU CTFG IVD workshop in Sweden later this year.
The full program of the dialogue meeting will be published in August 2019, but we recommend your early expression of interest to participate [here]. Since seats are limited to approx. 30, in order to facilitate meaningful discussions, the organizers will decide on registrations in excess. Please note, this is a national dialogue meeting and we encourage people outside DK to sign up for the workshop in Sweden. Thus, if you register now, you may expect a final confirmation no later than 26 August 2019.
More information at: https://laegemiddelstyrelsen.dk/en/devices/legislation-and-guidance/new-regulations/