The MDCG has published a very important Guidance on classification of medical devices under the MDR – Regulation (EU) 2017/745: MDCG 2021-24. The document mainly analyzes the classification rules of Annex VIII of the MDR and most importantly provides examples for each Rule and the applicable classes. Moreover, it includes some useful definitions of for ex. Substance, Integrated or incorporated diagnostic function, Essential impact, etc. It should be noted though that the guidance does not constitute a legally binding . . .
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