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 devices
(Text with EEA relevance)
Article 1
Designation of expert panels
Article 2
Appointment of advisors and establishment of the central list
Article 3
Sub-groups
Article 4
Term of office
Article 5
Election of the Chair and Vice-Chair
Article 6
Voting rules
Article 7
Coordination committee
Article 8
Preparation of opinions, views or positions
Article 9
Common rules of procedure
Article 10
Secretariat
Article 11
Remuneration
Article 12
Independence, impartiality and objectivity
Article 13
Commitment
Article 14
Transparency
Article 15
Confidentiality
Article 16
Entry into force and date of application
ANNEX
REMUNERATION OF ADVISORS
|
Regulation (EU) 2017/745 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 opinion |
Provision of a view of the performance of an in vitro diagnostic medical device |
Chair/Vice-Chair |
N/A |
2 |
2 |
Rapporteur |
1 |
5 |
4 |
Co-rapporteur |
1 |
5 |
4 |
Reviewing members (*1) |
N/A |
0,5 |
0,5 |
Advisors assigned pursuant to Article 2(6) of this Decision |
N/A |
2 |
2 |
Complexity of task (indicative criteria (*2)) |
Acting as |
Allowance in full day equivalents |
||||||||
Category I — simple matter
|
Chairperson |
2 |
||||||||
Rapporteur |
3 |
|||||||||
Co-rapporteur |
3 |
|||||||||
Reviewing member |
0,5 |
|||||||||
Advisors assigned pursuant to Article 2(6) of this Decision |
1 |
|||||||||
Category II — complex matter
|
Chairperson |
3 |
||||||||
Rapporteur |
5 |
|||||||||
Co-rapporteur |
5 |
|||||||||
Reviewing member |
1 |
|||||||||
Advisors assigned pursuant to Article 2(6) of this Decision |
2 |
|||||||||
Category III — very complex matter
|
Chairperson |
4 |
||||||||
Rapporteur |
7 |
|||||||||
Co-rapporteur |
7 |
|||||||||
Reviewing member |
2 |
|||||||||
Advisors assigned pursuant to Article 2(6) of this Decision |
2 |