10/31/2011

Obelis O.E.A.R.C.

Commission Decision on the European Databank on Medical Devices

Commission Decision of 19 April 2010 on the European Databank on Medical Devices:

Articles 5 and 6 - Competent Authorities will have just under 2 years (until 30 April 2012) to enter information on manufacturers, ARs and devices for all medical devices currently on the market and those going on until 1st May 2011.

How are the European Authorities going to go about collecting this information? Obelis Experts presume that it will most probably come from:
- All device manufactures in their country
- All E.A.Rs in their country.

By 1st May 2011, Competent Authorities had to obtain all information in the Annex which includes certificates from Notified Bodies and clinical trials.

GMDN are not expected to be mandated for this task, any “internationally recognised nomenclature” can be used, but it will be subject to the national laws by each member state.

Obelis Experts view this as a mammoth task requiring evaluation, preparation and careful planning by the European Authorities which will most probably result in different type of requests for information by the Competent Authorities.

You may find a copy of this decision for download on our website.

If you have any other questions regarding this update feel free to contact us.