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Products without an intended medical purpose (MDR 2017/745 Annex XVI)

비 의료목적 기기

RELATED    Act, regulation, standard or guidance
MDR 2017/745 Article 1(2) and Annex XVI List of groups of products without an intended medical purpose referred to in article 1(2)
MDR 2017/745 Annex 2 Technical documentation
Implementing Regulation (EU) 2022/2346 Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
Implementing Regulation (EU) 2022/2347 Rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose
DOCUMENTATION    
의료목적을 가진 기기와 동일하게 Technical documentation을 구성한다.
SUAMMARY    
제조업자는 Implementing Regulation (EU) 2022/2346의 부속서에 해당되는 기기에 적용되는 위험관리와 안전을 위한 정보 요구사항을 충족시켜야 한다.
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RELATED DATA   Related Act, regulation, standard or guidance
Manufacturer incident report 2020
Declaration of interest (DOI) form - Call for expression of interest for expert panels on medical de…
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