Edastuskiri

Dear Heads of Service*,

I am writing to you in order to request confirmation of nominations of national experts who would be available for joint assessments in the field of medical devices, as per Article 40 of Regulation (EU) 2017/745 (MDR) and Article 36 of Regulation (EU) 2017/746 (IVDR).

Joint assessments and subsequent designations and re-assessments of notified bodies are key to ensure effective implementation of the Regulations as well as availability of devices and a high level of patient safety thereof.  Under the Regulations, joint assessments are a joint responsibility for the Commission and Member States. The role of national experts is pivotal for the conduct of the joint assessment process.

We would be grateful if you could confirm the national experts from your country that will be available to carry out joint assessments in 2026 to the corresponding functional mailbox ([email protected]) as soon as possible and, in any case, no later than 12  December 2025.  On nomination please provide the following information relating to each nominated expert:

(i)                 Name and work e-mail address

(ii)              Regulation to which the nomination refers (MDR, IVDR or both)

(iii)            The experts’ corresponding curricula, as well as information on their specific qualifications with regard to type of devices and areas of knowledge.

Note that the above information is required for each nomination (even if it has been provided in the past) as personal details are not kept on file from previous years.  

Due to the number of upcoming re-assessments, we would appreciate if you could also explore the possibility of nominating additional experts who would be available to participate in joint assessment teams in 2026.

We ask that you please also consider the competence required for re-assessments (e.g. experts competent in the assessment of technical / clinical evaluation / performance evaluation documentation reviews).

*Reminder to Heads of Service: please inform this mailbox should there be a change of Head of Service or if any of your contact details need to be updated.

Kind regards,

Máiréad

Máiréad Finucane

European Commission
Health & Food Safety Directorate General (DG SANTE)

Directorate F – Health and food audits and analysis

Unit F.5 (Health Protection)

Grange, Dunsany, Co. Meath, Ireland

Tel: +353 46 9061 950

E-mail: [email protected]