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Declaration of interest (DOI) form - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Privacy statement - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Current performance of COVID-19 test methods and devices and proposed performance criteria - Working document of Commission services
Application form - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) -
Procedural guidance on declaration of interests - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Declarations on confidentiality and commitment - Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
Meetings of MDCG and subgroups – 2019
MDCG Working Group 11: In vitro diagnostic medical devices (IVD) - Terms of reference
Notifications under Directive 98/79/EC (In Vitro Diagnostic Devices, IVDD) National Competent Authority Reports (NCARs) exchanged in 2015 at EU level
Notifications under Directive 98/79/EC (In Vitro Diagnostic Devices, IVDD)
Guidance document - In vitro diagnostic medical devices - CE marking of blood based in vitro diagnostic medical devices for variant Creutzfeldt-Jakob Disease (vCJD) based on detection of abnormal PrP (host protein) - MEDDEV 2.14/4
Guidance document - In vitro diagnostic medical devices - Borderline and Classification issues. A guide for manufacturers and notified bodies - MEDDEV 2.14/1 rev.2
Summary of responses to public consultation - Revision of directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10
Guidance document - In vitro diagnostic medical devices - Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices - MEDDEV 2.14/3 rev.1
Requirements for in vitro diagnostic kits measuring parameters which can be used for evaluating the risk of trisomy 21
Guidance document - In vitro diagnostic medical devices - Research Use Only products - MEDDEV 2.14/2 rev.1
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