Glossary · Regulation
MDR
EU Medical Device Regulation (2017/745)
The MDR is the EU regulation, fully applicable since May 2021, that governs medical devices including software, with classes I, IIa, IIb and III and CE marking requirements.
Rule 11 puts most decision-supporting software in class IIa or higher, which is why a health app must decide early whether it diagnoses or only records.
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Definitions written by Anpheros from the official sources linked on each page. General information about standards and regulation, not legal or medical advice. All terms →