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.
|Class||Option 1||Option 2|
|Without custom made or investigational devices|
|I||EU 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 IX||Part A of Annex XI|
|IIa||Chapter I and III of Annex IX and Section 4 of chapter II of Annex IX at least one representative device for each category of devices||Technical 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|
|IIb||Chapter 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.|
|III||Annex IX||Annex X coupled with a conformity assessment as specified in annex XI|
|Custom made devices|
|III||Annex XIII & Chapter 1 of Annex IX||Annex 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.|
|I||Section 5.2 (device incorporating medicinal Substance)of annex IX||Section 6 (specific additional procedures)of Annex X|
|Transplants, tissues or cells of animal origin, or their derivatives apply additional below mentioned section with first section of respective class.|
|I||Section 5.3 (tissue, cell or human origin) of annex IX||Section 6 of Annex X|
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
|I||Section 5.4 (absorb locally or disperse in human body) of annex IX||Section 6 of Annex X|
If you need to know which document require in which conformity procedure contact to us or wait for our blog.