Notified Body Confirmation Letter – EU 2023/607
6 June 2023
The European Commissioners have issued a new confirmation letter on the recent amendments to the Medical Device Regulation (MDR + IVDR).
The eagerly awaited publication of the Template for NB – Confirmation letter in the framework of Regulation (EU) 2023/607 has now been officially communicated by the European Commission.
The MDR and IVDR were amended by Regulation (EU) 2023/607 (entered into force on March 20, 2023) which led to the extension of the transition period and the deletion of the “sell-off dates”.
Regulation (EU) 2023/607 provides for the extension of certain Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) certificates.
Notified bodies use the new EC form to confirm that the manufacturer (including the devices concerned) meets the requirements of Regulation (EU) 2023/607 and is therefore eligible for the extended transition period.
For competent authorities, healthcare professionals, users, authorised representatives and markets recognising CE marking, this form, completed by a notified body, is very helpful in determining whether devices can still be legally placed on the market with MDD or AIMDD certificates.
Essential conditions for a renewal:
- No unacceptable risk to health or safety
- No significant changes in design and intended use
- Continuous compliance with the (AI)MDD
- MDR compliant quality management system (QMS) established by May 26, 2024
- Conformity assessment application submitted by May 26, 2024 and agreement signed by the manufacturer and a notified body by September 26, 2024.
