Commission Implementing Decision (EU) 2025/1324of 7 July 2025amending Implementing Decision (EU) 2019/1396 as regards certain administrative aspects related to expert panels and as regards the designation of an additional expert panel in the field of medical devices(Text with EEA relevance)

Article 54(1)

Regulation (EU) 2017/746

Article 48(6)

Decision on whether a scientific opinion should be developed (Yes/No)Development and provision of a scientific opinionProvision of a view of the performance of an in vitro diagnostic medical deviceChair/Vice-ChairN/A33Rapporteur155Co-rapporteur155ReviewerN/A11Advisor assigned for a specific taskN/A11

(2) Table 2 is replaced by the following:

Table 2

Maximum number of working days for which experts may be remunerated for tasks under Article 55(3), Article 61(2), Article 106(10), points (a) to (f), and Article 106(11) of Regulation (EU) 2017/745 and Article 50(3) of Regulation (EU) 2017/746

Each of these criteria may be applied independently

Complexity of task (indicative criteria)Acting asRemuneration in in full-day equivalents

Category I

opinion based on examination of a low volume of data, documents and literature

no consultation of other scientific bodies

no information available from stakeholders including patient organisations and healthcare professionals

indicatively, less than three months to accomplish task

Chair/Vice-Chair2Rapporteur3Co-rapporteur3Reviewer0,5Advisor assigned for a specific task0,5

Category II

opinion based on a significant volume of data, documents and literature

feedback following consultation, if any, of other scientific bodies to be examined

information available from stakeholders including patient organisations and healthcare professionals, to be examined

indicatively, three to six months to accomplish task

Chair/Vice-Chair3Rapporteur5Co-rapporteur5Reviewer1Advisor assigned for a specific task1

Category III

opinion based on a significant volume of data, documents and literature

high volume of feedback following consultation, if any, of other scientific bodies to be examined

large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined

indicatively, more than six months to accomplish task

Chair/Vice-Chair4Rapporteur7Co-rapporteur7Reviewer2Advisor assigned for a specific task2

Category IV

contributions based on a significant volume of data, documents and literature

high volume of feedback following consultation, if any, of other scientific bodies to be examined

large amount of information available from stakeholders including patient organisations and healthcare professionals, to be examined

indicatively, more than 12 months to accomplish task

Chair/Vice-Chair8Rapporteur21Co-rapporteur21Reviewer4Advisor assigned for a specific task4