Commission Implementing Decision (EU) 2020/350 of 28 February 2020 amending Decision 2002/364/EC as regards definitions of first–line assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays
Proposed act with possible EEA relevance
Act under scrutiny by EEA EFTA
Draft Joint Committee Decision (JCD) under consideration
Entry into force of Joint Committee Decision (JCD) pending
Incorporated into the EEA Agreement and in force
Incorporated into the EEA Agreement but no longer in force
Legal status
EU legal act incorporated into the EEA Agreement by a Joint Committee Decision (JCD) Area (EEA Agreement)
II Technical Regulations, Standards, Testing and Certification
II.XXX Medical Devices
Joint committee decision (JCD)
038/2021 In force in the EEA
Yes Legal documents
Commission Implementing Decision (EU) 2020/350 of 28 February 2020 amending Decision 2002/364/EC as regards definitions of first–line assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays
Framkvæmdarákvörðun framkvæmdastjórnarinnar (ESB) 2020/350 frá 28. febrúar 2020 um breytingu á ákvörðun 2002/364/EB að því er varðar skilgreiningar á skimunarprófum og staðfestingarprófunum, kröfur til tækja til sjálfsprófunar og kröfur til HIV- og HCV-hraðprófa, staðfestingarprófana og viðbótarprófana
Durchführungsbeschluss (EU) 2020/350 der Kommission vom 28. Februar 2020 zur Änderung der Entscheidung 2002/364/EG in Bezug auf die Begriffsbestimmungen für erstmalige Tests und für Bestätigungstests, die Anforderungen an Produkte zur Eigenanwendung und die Anforderungen an HIV- und HCV-Schnell-, Bestätigungs- und Ergänzungstests
Kommisjonens gjennomføringsbeslutning (EU) 2020/350 av 28. februar 2020 om endring av vedtak 2002/364/EF med hensyn til definisjonen av førstelinjetester og bekreftende tester, krav til utstyr til selvtesting og krav til hurtigtester og bekreftende og supplerende tester for HIV og HCV
History
06.02.2021
Adopted JCD confirmed entry into force date
02.03.2021
Compliance date in the EEA
05.02.2021
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
14.10.2020
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
28.02.2020
Adoption date in the EU
02.03.2021
Compliance date in the EU
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