News Category: Regulatory news
We have published a new certificates of free sale application form for devices qualifying under Regulation 2023/607.
This application form is available on our certificates of free sale webpage.
We have also introduced certificate expiry dates for our certificates as outlined below.
Who should use the HPRA certificate of free sale application form for devices qualifying under Regulation 2023/607?
If your devices qualify under Regulation 2023/607, and you would like a certificate of free sale from the HPRA for those devices, we will request you to complete and submit our new application form together will all other required documentation.
For devices that qualify under Regulation 2023/607, this will include:
- Declaration of conformity,
- Manufacturer self-declaration letter,
- Proof of payment,
- Device schedule,
- Unless otherwise stated in the declaration of conformity, a letter confirming the physical site of manufacturer.
We will introduce a three-year expiry date for such certificates from the date of issue of the certificate.
What form should I complete for devices that will not qualify under Regulation 2023/607?
If your devices do not qualify under Regulation 2023/607, and you would like a certificate of free sale from the HPRA, we will request you to complete and submit our existing MDD/AIMDD application form together will all other required documentation.
This application form is available on our certificates of free sale webpage.
We will introduce an expiry date of May 2024 for such certificates.
Stakeholder engagement
We encourage engagement from all stakeholders. If you have any questions about legislative requirements or the implementation of the MDR please email us at devices@hpra.ie.
We will continue to discuss our certificates of free sale process with EU colleagues in the spirit of harmonisation and we may amend our process in this regard.