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Conformity Assessment Procedure

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Conformity Assessment Procedure

According to EU MDR, conformity assessment describes a procedure, which determines whether a medical device complies with the requirements in the MDR.

To know which conformity assessment procedure apply to your product you have refer Chapter V Classification and conformity procedure and this procedure is a proof that the GSPR are fulfilled. Devices shall be divided in into classes I, IIa, IIb and III. Assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.

Annex IX- Quality Management System and on Assessment of Technical Documentation;

Chapter I – Quality Management System

Chapter II – Assessment of technical Documentation

Chapter III – Administrative provision

Annex X – Conformity Assessment based on Type-Examination

Part A – Production Quality Assurance

Part B – Product Verification

Annex XI- Conformity Assessment based on Product Conformity Verification

Annex XIII- Procedure for Custom Made devices

* for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device.

You can used below table to appropriate conformity assessment procedure for your product.

ClassOption 1Option 2
Without custom made or investigational devices
IEU Declaration of conformity  referred to in Article 19 after drawing up the technical documentation set out in annexes II and III
If the devices are placed on market in sterile condition, have a measuring function or are reusable surgical instrument.Chapter I and III of Annex IXPart A of Annex XI
IIaChapter I and III of Annex IX and Section 4 of chapter II of Annex IX at least one representative device for each category of devicesTechnical Documentation set out in annexes II and III coupled with conformity assessement as specified in section 10 or section 18 of annex XI at least one representative device for each category of devices
IIbChapter I and III of Annex IX and Section 4 of chapter II of Annex IX at least one representative device per generic device group.Annex X coupled with a conformity assessment as specified in annex XI at least one representative device per generic device group.
IIIAnnex IXAnnex X coupled with a conformity assessment as specified in annex XI
Custom made devices
IAnnex XIII
IIa
IIb
IIIAnnex XIII & Chapter 1 of Annex IXAnnex XIII & Part A of Annex XI
Medicinal product (Substance, human Blood or human plasma) apply additional below mentioned section with first section of respective class.
ISection 5.2 (device incorporating medicinal Substance)of annex IXSection 6 (specific additional procedures)of Annex X
IIa
IIb
III
Transplants, tissues or cells of animal origin, or their derivatives apply additional below mentioned section with first section of respective class.
ISection 5.3 (tissue, cell or human origin) of annex IXSection 6 of Annex X
IIa
IIb
III
 

If the devices composed of substances or of combination of substances the intended to be introduced into the human body via body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body

ISection 5.4 (absorb locally or disperse in human body) of annex IXSection 6 of Annex X
IIa
IIb
III

If you need to know which document require in which conformity procedure contact to us or wait for our blog.

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