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Regulation

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

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

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

Regulation

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

Standards [CURRENT]

ISO 10651-4

Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
Edition 2023-03

Pre-standard

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

Pre-standard

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

Technical rule [CURRENT]

ISO/TR 21582

Pyrogenicity - Principles and methods for pyrogen testing of medical devices
Edition 2021-07

Pre-standard

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

Administrative provision

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

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