Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down,... (32024R2699)
INHALT
Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices
- COMMISSION IMPLEMENTING REGULATION (EU) 2024/2699
- of 18 October 2024
- laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and
- in vitro
- diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices
- (Text with EEA relevance)
- Article 1
- Subject matter
- Article 2
- Information exchange related to the planning and forecast of the joint clinical assessments and joint scientific consultations
- Article 3
- Information exchange related to the selection of medical devices and in vitro diagnostic medical devices for joint clinical assessment
- Article 4
- Information exchange with the Coordination Group and its EHT Subgroup and JCA Subgroup
- Article 5
- Information exchange related to the identification of individual experts in the context of joint clinical assessments and joint scientific consultations
- Article 6
- Information exchange on horizontal scientific and technical matters related to joint clinical assessment and joint scientific consultation
- Article 7
- Secure exchange of information
- Article 8
- Protection of confidential information
- Article 9
- Failure to respect the obligations of professional secrecy
- Article 10
- Entry into force
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