Health Products Regulatory Authority (HPRA) released a new application form for the free sale certificates for medical devices qualifying under Regulation 2023/607. All certificates now have been certified together with their expiry dates.
For a free sale certification application from HPRA for devices qualified under Regulation 2023/607, the responsible person has to complete and submit the new form together with other documentation which is:
Declaration of conformity
Manufacturer self-declaration letter
Proof of payment
Device schedule
Authentication letter of the manufacturer’s physical site
For devices that are not qualified under Regulation 2023/607, the application of a free sale certificate can be applied by submitting the existing MDD/AIMDD application form together with the required documents as above.
Referring to Regulation 2023/607 that was enforced on March 2023, devices that qualify for the MDR transitional period extensions under the regulation are; Class I up classified devices, Class Im devices, Class Is devices, Class IIa and IIb devices, Class IIb implantable devices, Class III implantable devices, and Class III custom-made devices.
HPRA stipulated the certificates’ expiry date for qualified devices would be 3 years from the issuance date, while for the non-compliance devices, the expiry date would be May 2024. All stakeholders are encouraged to engage with the requirement to prevent market disruption.
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