Conformity Assessment Options for Products Failing under the MDR
Overview
Purpose (+) Scope
The conformity assessment route for CE marking varies according to the assigned class of device as describes in MDR Article 52 and in the MDR Annex IX, Annex X and Annex XI depending on the device class, manufacturers have some choice regarding the conformity assessment route.
Conformity Assessment Options
Class I
Annex II and Annex III
Class I (special): With measuring function, sterile, or reusable
Annex II, Annex III and Annex IX,
or
Annex XI Part A
Class IIa
Annex II, Annex III and Annex IX of each category of devices
or
Annex X coupled with Annex XI Part A or Annex XI Part B
Class IIb
Annex II, Annex III and Annex IX, of each generic category of devices
or
Annex X coupled with Annex XI Part A or Annex XI Part B
Class IIb (special): Implantable devices
Paragraph
Class III
Annex II, Annex III and Annex IX
or
Annex X coupled with Annex XI Part A or Annex XI Part B
Custom-made Devices
(a) Not implantable: Annex XIII
(b) Implantable Class III: Additionally Annex IX or Annex XI Part A
Mentionned Annexes
Annex II – Technical documentation
Annex III – Technical documentation on post-market surveillance
Annex IX – Conformity assessment based on a quality management system and assessment of the technical documentation
Annex X – Conformity assessment based on type examination
Annex XI – Conformity assessment based on product conformity verification – Part A: Production Quality Assurance
Annex XI – Conformity assessment based on product conformity verification – Part B: Product Verification
Annex XIII – Procedure for Custom-Made Devices
References
Regulation (EU) 2017/745 MDR: 02017R0745 — EN — 24.04.2020 — 001.001 (consolidated version)
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Template – Product Qualification and Classification under the EU IVDR 2017/746 (v.1.0)
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Checklist – ISO 13485 2016 Internal Audit (v.1.0)
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Template – SOP Master Validation Test Plan (v.1.0)
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Template – Technical Documentation Table of Content according to the IVDR (v1.0)
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Template – SOP Technical Documentation according the IVDR (v1.0)
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