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Technical rule [CURRENT]

ONR 112069-1

Guideline for the validation and routine control of sterilization processes with moist heat for medical device products - Part 1: General
Edition 2009-07-01

Technical rule [CURRENT]

ONR 111107-5

Quality management for supply with medical devices for rehabilitation - Part 5: Wheelchairs - Selection and adaptation of electrically powered wheelchairs and auxiliary drive systems
Edition 2013-05-01

Administrative provision

MedPDG§96a§97aBek

Bekanntmachung nach § 96a Absatz 3 und § 97a Absatz 1 Satz 2 und Absatz 2 des Medizinprodukterecht-Durchführungsgesetzes zur Regelung des Übergangszeitraums bis zur vollen Funktionsfähigkeit der Europäischen Datenbank für Medizinprodukte nach Artikel 33 der Verordnung (EU) 2017/745 und Artikel 30 der Verordnung (EU) 2017/746
Edition 2022-05-16

Technical rule [CURRENT]

ONR 112069-2

Guideline for the validation and routine control of steam sterilization processes for medical devices in/for in health care institutions - Part 2: Further specifications
Edition 2009-07-01

Technical rule [CURRENT]

ONR 111107-4

Quality management for supply with medical devices for rehabilitation - Part 4: Wheelchairs - Selection and adaptation of manually propelled wheelchairs
Edition 2011-08-01

Technical rule [CURRENT]

ONR 111107-3

Quality management for supply with medical devices for rehabilitation - Part 3: Rehabilitation technical activities - Process quality for all devices
Edition 2008-08-01

Regulation

EUV 2021/2226

Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices
Edition 2021-12-14

Administrative provision

2013/473/EUEmpf

Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices
Edition 2013-09-24

Gesetz zur Änderung des Bevölkerungsstatistikgesetzes, des Infektionsschutzgesetzes, personenstands- und dienstrechtlicher Regelungen sowie der Medizinprodukte- Abgabeverordnung
Edition 2023-07-17

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