Module 15 Presentations

4/15/2024

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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© NAMSA 2021

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Certification process MDR

Within scope of 2017/745

Article 2

Classification

Article 51, Annex VIII

Conformity assessment route

Article 52

General Safety and Performance Requirements

Article 5, Annex I

Technical documentation

Annex II, III

Conformity assessment process

Annex IX, X, XIA, XIB

Declaration of conformity

Article 19, Annex IV

CE mark

Article 20, Annex V

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