The Maltese Medicines Authority (MMA), in collaboration with other EU competent authorities, has introduced additional mandatory national measures to increase transparency of medical device and in vitro medical device registrations.
New Mandatory Requirements:
All medical devices including in vitro medical devices, regardless of classification must be registered with the competent authority by the authorised representative on behalf of the manufacturer and:
- Before registering on EUDAMED, and
- Before placing any devices on the EU market
Even after EUDAMED is fully functional, prior notification to the competent authority is required before registering devices on EUDAMED and before market placement.
This notification is submitted by the authorised representative on behalf of the manufacturer
What Does This Mean for Existing Device Registrations:
For devices registered with the MMA:
- No immediate action needed until EUDAMED becomes mandatory
For devices registered on EUDAMED but not with the MMA
- Must now be additionally registered with the MMA as soon as possible over the coming months.
No Exemptions:
- All devices, regardless of classification, must be registered with the MMA.
- This includes higher-class devices that previously weren’t required to be registered whilst under the Directives or the transitional provisions of the Regulations.
Action Required by Clients:
Action is required; however, the Next Steps will provide further information. Currently this does not restrict your ability to sell or market your devices in the EU. However, a timely registration is crucial to remain compliant with EU and national requirements.
Next Steps:
Advena will be contacting clients individually to guide them through the process, helping to assess which devices need a registration, collecting the data and information of the applicable devices, and completing and submitting the necessary documentation.
