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In accordance with §103 of the MDR, the Medical Device Coordination Group (MDCG) has been established. The MDCG and its sub-groups publish guidances that provide clarification and support to national competent authorities, notified bodies and economic operators on the details of the implementation of the MDR and IVDR. The members of the MDCG ...
Additionally, the EU member state accrediting the notified body will then inform the European Commission that the product complies with the essential requirements (or not). [1] [2] [3] More generally, a notified body is an independent, accredited body which is entitled by an authorized accrediting body. Upon definition of standards and ...
Language European Parliament Council of the European Union European Commission; Bulgarian: Европейски парламент (Evropejski parliament)
The agencies of the European Union (formally: Agencies, decentralised independent bodies, corporate bodies and joint undertakings of the European Union and Euratom) are bodies of the European Union and Euratom established as juridical persons through secondary EU legislation and tasked with a specific narrow field of work. [1] They are distinct ...
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union.
other bodies of the EU established through primary (treaty) legislation, either as international law bodies (the European Investment Bank Group entities, the European University Institute, the European Stability Mechanism and the Unified Patent Court) or as bodies without juridical personality (the European Ombudsman, the advisory bodies to the ...