External
Documents
Service
We have compiled all relevant links for you to the best of our knowledge, where you can find further important documents. We accept no responsibility for the content and currency of the documents on the external sites.
Legal documents
EU-Regulation (MDR)
-
Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
(EUR-Lex) - Implementing Regulation (EU) 2021/2226 as regards electronic instructions for use of medical devices
(EUR-Lex) -
(EUR-Lex)
- Further Implementing Regulations regarding the MDR
(EUR-Lex) - Further Delegated Regulations regarding the MDR
(EUR-Lex)
EU-Regulation (IVDR)
National laws Germany
- Laws and Regulations
(BfArM)
National laws Austria
Harmonised standards
Lists of harmonised standards under regulations and directives
- List of harmonised standards under Regulation (EU) 2017/745 for Medical Devices
(EUR-Lex) - List of harmonised standards under Regulation (EU) 2017/746 for In vitro diagnostic medical devices
(EUR-Lex) - List of harmonised standards under Directive 93/42/EEC for Medical Devices
(EUR-Lex) - List of harmonised standards under Directive 98/79/EC for In vitro diagnostic medical devices
(EUR-Lex)
Guidelines
MDCG Guidance documents
EK-Med documents
Team NB documents
IG-NB documents
IMDRF documents
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