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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