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Table 1 Regulatory framework in the EU on medical devices

From: Artificial intelligence as a medical device in radiology: ethical and regulatory issues in Europe and the United States

Directive 93/42/EEC Directive on medical devices
Will be replaced by MDR on 26 May 2020
MEDDEVS Non-binding guidelines on legislation related to medical devices
MDR Regulation on medical devices
Applies from 26 May 2020
Repeals Directive 93/42/EEC
IVDR Regulation on in vitro diagnostic medical devices
Applies from 26 May 2022
  1. MDR, Medical Device Regulation; IVDR, In Vitro Diagnostic Medical Device Regulation; EEC, European Economic Community