In anticipation of the European regulations on medical devices and in vitro diagnostic medical devices, the FAMHP has updated the “My company” and “My activities” applications in its web portal.
The main changes are:
- The addition of risk classes from Regulations (EU) 2017/745 and (EU) 2017/746.
- Healthcare facilities will be able to register and report their “in-house” manufacturing and reprocessing of single-use medical devices activities, once a legal basis is established.
- Activities that were previously listed under a single table will now appear in two separate tables (activities also be registered in the Eudamed or not):
- Multiple activities related to the same area of activity will now be consolidated into a single activity
- “System and package assemblers” and “sterilisers” have been consolidated into the single “system/package producer” activity.
Web portal users do not have to take any particular action. Nevertheless, validity of the information provided should be checked on a regular basis and updated accordingly.