May 26, 2023
European Commissioners have issued a new confirmation letter regarding recent amendments to the Medical Devices Regulation (MDR).
Medical device manufacturers have anticipated the publication of “Template for NB - Confirmation letter in the framework of Regulation (EU) 2023/607”, and industry as well as healthcare providers are anxiously waiting for the form to come into use.
As we have previously reported, the MDR and IVDR have been amended by Regulation (EU) 2023/607, leading to the extension of the MDR transitional period and removal of the "sell-off" dates in the MDR and IVDR.
Regulation (EU) 2023/607 came into force on March 20, 2023, providing for the extension of certain Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) certificates. However, the expiry dates listed on those certificates have not changed, which makes it difficult to determine whether a device is still lawfully placed on the market or not.
The new EC form is to be used by Notified Bodies to confirm that the manufacturer (and devices in question) meets the requirements set out in Regulation (EU) 2023/607, and therefore is eligible for the extended transitional period.
Such a form, completed by a Notified Body, will help Competent Authorities, healthcare professionals, users, Authorized Representatives and other markets acknowledging the CE mark to determine whether the devices are still allowed to be lawfully placed on the market under the MDD or AIMDD certificate.
As a reminder, the conditions for extension are:
- Continuous compliance with (AI)MDD
- No significant changes in design and intended purpose
- No unacceptable risk to health or safety
- Manufacturer’s quality management system (QMS) in place by 26 May 26, 2024 pursuant to MDR requirements
- Application for conformity assessment submitted by May 26, 2024, and a contract between manufacturer and Notified Body in place by September 26, 2024
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