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EUV 2020/666
Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies
Edition
2020-05-18
EUV 2017/746Ber
Corrigendum to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Edition
2019-05-03
EUV 2017/746Ber 2021
Corrigendum to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Edition
2021-07-01
EUV 2022/1107
Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council
Edition
2022-07-04
ISO 10651-4
Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
Edition
2023-03
ISO/TS 4425
Genomics informatics - Data elements and their metadata for describing the microsatellite instability (MSI) information of clinical massive parallel DNA sequencing
Edition
2023-04
ISO/TS 22421
Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
Edition
2021-01
ISO/TR 21582
Pyrogenicity - Principles and methods for pyrogen testing of medical devices
Edition
2021-07
ISO/TS 22456
Sterilization of healthcare products - Microbiological methods - Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
Edition
2021-03
EUB 2019/1396
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
Edition
2019-09-10