Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devicesText 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/A22Rapporteur154Co-rapporteur154Reviewing membersN/A0,50,5Advisors assigned pursuant to Article 2(6) of this DecisionN/A22

1. For tasks referred to in Articles 55(3), 61(2), 106(10)(a) to (f) and 106(11) of Regulation (EU) 2017/745 and Article 50(3) of Regulation (EU) 2017/746, divided into categories depending on their level of complexity, the maximum number of working days is specified in Table 2.

Table 2

Maximum number of working days for which experts may be remunerated for tasks under Articles 55(3), 61(2), 106(10)(a) to (f) and 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 asAllowance in full day equivalents

Category I — simple matter

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

Chairperson2Rapporteur3Co-rapporteur3Reviewing member0,5Advisors assigned pursuant to Article 2(6) of this Decision1

Category II — complex matter

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

Chairperson3Rapporteur5Co-rapporteur5Reviewing member1Advisors assigned pursuant to Article 2(6) of this Decision2

Category III — very complex matter

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

Chairperson4Rapporteur7Co-rapporteur7Reviewing member2Advisors assigned pursuant to Article 2(6) of this Decision2

1. The remuneration shall be conditional on the completion of the relevant tasks as per the common rules of procedure.