EU Releases New Template for Notified Body Confirmation Letter

The European Commission has released a new template for the notified body confirmation letter, a critical document outlining the status of a formal application, written agreement, and appropriate surveillance under Regulation (EU) 2024/1860. This template is designed to standardize and streamline the documentation process, ensuring consistency and clarity in the communications between notified bodies and applicants.

The confirmation letter serves as an official document that confirms the status of a formal application, the establishment of a written agreement, and the implementation of appropriate surveillance measures. The letter includes essential details such as the notified body’s name, the manufacturer’s information, and the specific devices covered under the formal application and agreement.

The notified body confirmation letter template categorizes devices into two tables:

• • Table 1: Devices for which an IVDR application has been received, a written agreement concluded, and for which the notified body is also responsible for appropriate surveillance under Directive 98/79/EC.
  • Table 2: Devices for which an IVDR application has been received and a written agreement concluded, but the notified body has not yet taken responsibility for appropriate surveillance under Directive 98/79/EC.

For devices covered by certificates issued under Directive 98/79/EC that expired after May 26, 2022, and before July 9, 2024, the letter confirms the manufacturer’s compliance with signing the written agreement under IVDR by the expiry date or obtaining derogations or exemptions from the competent authority by July 9, 2024.

The transition timelines for these devices, contingent on continued compliance with Article 110.3c of IVDR (as amended by (EU) 2024/1860), are as follows:

• • December 31, 2027, for devices covered by an IVDD certificate, regardless of their risk class under the IVDR.
  • December 31, 2027, for Class D devices.
  • December 31, 2028, for Class C devices.
  • December 31, 2029, for Class B devices and Class A sterile devices.

You can read the official update and download the Notified Body Confirmation Letter on the European Commission’s website.

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