Module 15 2022
5/19/2022
MDR Structure
• Recitals – “whereas” statements (101 statements) • set out the reasons for the content of the articles – why this is happening – statement of purpose • Chapters I – X (Articles 1-123) • “enacting terms”, the normative part of the act – what you need to do – enumerate in detail specific legal requirements • Annexes I – XIII • generally contain rules or technical data which, for practical reasons do not appear in the enacting terms (Articles) – how you do it
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Certification process 93/42/EEC
Within scope of 93/42/EEC
Article 1
Classification
Article 9, Annex IX
Conformity assessment route
Article 11
Essential requirements
Article 3, Annex I
Technical documentation
Annex II, III, VII
Conformity assessment process
Annex II-VII
Declaration of conformity
Annex II-VII
CE mark
Annex XII
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