In anticipation of the European regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), the FAMHP has updated the “My company” and “My activities” applications in its web portal.
The FAMHP web portal offers a number of applications for the exchange of information, data and documents with the competent services of the FAMHP.
What are the main changes?
- The addition of risk classes from Regulations (EU) 2017/745 and (EU) 2017/746.
- Subject to the establishment of a legal basis, healthcare facilities will be able to register and report their “in-house” manufacturing and reprocessing of single-use medical devices activities.
- Activities that were previously listed under a single table will now appear in two separate tables:
- One table containing activities that will also be registered in the Eudamed European web portal in the future: manufacturing, authorised representative, importer and system/package producer activities.
- One table containing activities that will not be registered in Eudamed in the future: activities involving custom medical device manufacturing, distributor, “in-house” manufacturing of medical devices by healthcare facilities, exporter and home-care technicians installing medical devices (Article 59 of the Law of 15 December 2013).
- Multiple activities related to the same area of activity will now be consolidated into a single activity (for example, an actor who was previously registered as both an “authorised representative for manufacturer” and as an “authorised representative for custom manufacturer” will now be registered under the single “authorised representative” activity).
- “System and package assemblers” and “sterilisers” have been consolidated into the single “system/package producer” activity.
What actions do our web portal users need to take?
- All your information has been saved. You do not have to take any particular action. Nevertheless, we encourage you to check the validity of the information you have provided on a regular basis and update it accordingly.
For more information on the FAMHP’s web portal, please visit our FAQ.
In you have any questions or encounter any technical problems when using our applications, please email us at email@example.com.