MDR Extension: Notified Body Confirmation Letter

The European Commission (EC) has released a “Confirmation Letter” detailing recent amendments to the Medical Devices Regulation (MDR). This document, titled “Template for NB – Confirmation letter in the framework of Regulation (EU) 2023/607,” has been eagerly awaited by medical device manufacturers, the industry, and healthcare providers. This confirmation letter is pivotal following the changes introduced by Regulation (EU) 2023/607, which extended the MDR transitional period and eliminated the “sell-off” dates in both MDR and IVDR.

Implemented from March 20, 2023, Regulation (EU) 2023/607 extended specific certificates under the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). However, the expiration dates on these certificates remained unaltered, causing confusion about the legal status of devices in the market.

The newly introduced form is intended for use by Notified Bodies. It confirms that the manufacturer and the devices in question comply with the requirements outlined in Regulation (EU) 2023/607, thus qualifying for the extended transitional period. It also allows Notified Bodies to state that they will be taking on the responsibility (or not) of surveillance for the specified products. Notified Bodies completing this form will aid Competent Authorities, healthcare professionals, users, Authorized Representatives, and other stakeholders in verifying whether the devices can still be legally placed on the market under the MDD or AIMDD certificate.

In our experience, Competent Authorities do ask for this specific document and therefore we encourage its use.

Should you require any assistance in completing this form, or if you are in of an Authorized Representative to guide you through this process, please get in touch at info@specculo.com