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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