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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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