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Administrative provision

EUB 2022/757

Commission Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices
Edition 2022-05-11

Administrative provision

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

Regulation

EUV 2021/808

Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals and on the interpretation of results as well as on the methods to be used for sampling and repealing Decisions 2002/657/EC and 98/179/EC
Edition 2021-03-22

Regulation

EUV 2024/1860

Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices
Edition 2024-06-13

Regulation [New]

EUV 2024/2052

Commission Implementing Regulation (EU) 2024/2052 of 30 July 2024 amending Implementing Regulation (EU) 2021/808 as regards its scope and certain performance criteria of analytical methods for residues of pharmacologically active substances used in food- producing animals
Edition 2024-07-30

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

Administrative provision

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

Regulation

MedPRVsEUAnpV

Verordnung zur Anpassung des Medizinprodukterechts an die Verordnung (EU) 2017/745 und die Verordnung (EU) 2017/746 (Medizinprodukte-EU-Anpassungsverordnung - MPEUAnpV) (Artikel 1 Verordnung über die Meldung von mutmaßlich schwerwiegenden Vorkommnissen bei Medizinprodukten sowie zum Informationsaustausch der zuständigen Behörden (Medizinprodukte-Anwendermelde- und Informationsverordnung - MPAMIV); Artikel 5 Gebührenverordnung zum Medizinprodukterecht-Durchführungsgesetz und den zu seiner Ausführung ergangenen Rechtsverordnungen (Medizinprodukterecht-Durchführungsgesetz-Gebührenverordnung - MPDGGebV))
Edition 2021-04-21

Gesetz zur Änderung des Medizinprodukterecht-Durchführungsgesetzes und weiterer Gesetze
Edition 2021-05-12

Regulation

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

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