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2013/172/EUEmpf
Commission Recommendation of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union
Edition
2013-04-05
BS EN ISO 17664-1
Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Critical and semi-critical medical devices
Edition
2021-09-01
2020/C259/02
Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure
Edition
2020-08-07
EUV 2017/745Leitl
Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745
Edition
2020-05-19
EUB 2022/729
Commission Implementing Decision (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices
Edition
2022-05-11
EUV 2020/561
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
Edition
2020-04-23
EUB 2024/815
Commission Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products
Edition
2024-03-06
EUB 2021/1182
Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council
Edition
2021-07-16
EUV 2021/2078
Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)
Edition
2021-11-26
BS EN ISO 12417-1
Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products. General requirements
Edition
2024-02-28