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Procedure(s) for conformity assessment

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Guest user Created:   Sep 14, 2020 Last commented:   Sep 15, 2020

Procedure(s) for conformity assessment

I hope you are doing well. I am browsing through some of the documents in the EUMDR kit I bought a while back, I don't see procedure(s) for conformity assessment.
would you please point me to the right direction for a conformity assessment procedure.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Sep 15, 2020

The term "Conformity assessment" means the process demonstrating whether the requirements of the Medical device regulation EU MDR 2017/745 relating to a medical device have been fulfilled. Medical device manufacturers have to follow conformity assessment procedures before placing products on the market. With conformity assessment procedures manufacturers must prove compliance of the products with the essential requirements laid down in Medical Device Regulation.

However, there is no requirement in MDR that the conformity assessment procedure must be documented. In Article 52 - Conformity assessment procedures states that manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes 9 to 11.

  • EU MDR Annex 9 - Conformity assessment based on a quality management system and assessment of the technical documentation
  • EU MDR Annex 10 - Conformity assessment based on type examination
  • EU MDR Annex 11 – Conformity assessment based on product conformity verification

Here you can find the direct links to the Annexes:

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Sep 14, 2020

Sep 15, 2020