Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down r... (32025R0117)
Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices
- COMMISSION IMPLEMENTING REGULATION (EU) 2025/117
- of 24 January 2025
- laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and
- in vitro
- diagnostic medical devices
- (Text with EEA relevance)
- Article 1
- Subject matter
- Article 2
- Setting of request periods for joint scientific consultations
- Article 3
- Submission of requests for joint scientific consultations
- Article 4
- Exchange of information on the selected requests for joint scientific consultation
- Article 5
- Provision of information to the health technology developer on engagement in joint scientific consultations
- Article 6
- Selection of individual experts for joint scientific consultations
- Article 7
- Professional secrecy obligations of individual experts
- Article 8
- Briefing package and further data for joint scientific consultations
- Article 9
- Establishment of the template of the briefing package where the joint scientific consultation is carried out in parallel with the expert panel consultation
- Article 10
- List of issues to be discussed in the meeting for an exchange of views
- Article 11
- Input of individual experts on joint scientific consultation
- Article 12
- Consultation of stakeholder organisations during joint scientific consultation
- Article 13
- Meeting with the health technology developer
- Article 14
- Joint scientific consultation outcome document for joint scientific consultations carried out in parallel with the expert panel consultations
- Article 15
- Correspondence during joint scientific consultations
- Article 16
- Personal data processing
- Article 17
- Entry into force
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