On May 24th, 2023, the European Commission released a new template for Notified Bodies. This form is to be used as confirmation letter on the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation (EU) 2023/607 amending Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
Template for NB – Confirmation letter in the framework of Regulation (EU) 2023/607.
By completing this form, the Notified Body (NB) will confirm that:
- they have received a formal application (in accordance with Section 4.3, first subparagraph of Annex VII of MDR) AND
- they have signed a written agreement (in accordance with Section 4.3, second subparagraph of Annex VII of MDR)
with a manufacturer.
Furthermore, a division is made between devices for which an application is received and written agreement is concluded and for which the NB is also responsible for the appropriate surveillance of the corresponding devices under the applicable Directive and for those where an application is received and the written agreement is concluded but the NB has not yet taken the responsibility for appropriate surveillance of the corresponding devices under the applicable Directive.
In the case of devices covered by certificates issued under Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) that expired after 26 May 2021 and before 20 March 2023, without having been withdrawn, this letter also confirms that the manufacturer signed the written agreement under MDR by the date of MDD/AIMDD certificate expiry; or provided evidence that a competent authority of a Member State had granted a derogation or exemption from the applicable conformity assessment procedure in accordance with Article 59(1) of MDR or Article 97(1) of the MDR respectively, by the 20 Mar 2023 for the relevant devices.
What does this mean to you?
Medical device manufacturers who want to take advantage of the MDR transition (Regulation (EU) 2023/607) should take note of this new form.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
