Conformity assessment (CA) activity is the process describing whether the requirement of the MDR relating to a device have been fulfilled. It is one of the key elements of the existing regulatory approach which would call for high level of safety protection world-wide and would facilitate trade.
For all the devices, Annex IX to XI has laid out the conformity assessment procedures which needs to be followed by the manufacturers before placing their devices in the market.
Where, Annex IX states about Conformity Assessment Based on A Quality Management System and On Assessment of Technical Documentation.
Annex X states about Conformity Assessment Based on Type-Examination and Annex XI states about Conformity Assessment Based on Product Conformity Verification.
For Class III devices, other than custom-made or investigational devices – CA route will be as specified in Annex IX OR as CA specified in Annex X coupled with Annex XI.
For Class IIb devices, other than custom-made or investigational devices – CA route will be as specified in chapters I and III of Annex IX with the assessment of technical documentation specified in section 4 of the same annex of one representative device per generic group. Assessment of technical documentation as per section 4 of Annex IX will be applicable for all class IIb devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
The Conformity assessment for class IIb devices can also be based on type of examination specified in Annex X with conformity assessment based on product verification as indicated in Annex XI.
For Class IIa devices, other than custom-made or investigational devices – CA route will be as specified in chapters I and III of Annex IX with the assessment of technical documentation specified in section 4 of the same annex of at least one representative device per category of devices.
The technical documentation can be tailored as per Annex I & III with CA specified in sec.10 or 18 of Annex XI and it shall apply for at least one representative device per category of devices
For Class I devices, other than custom-made or investigational devices- should declare the conformity of products by issuing the EU Declaration of Conformity after creating the Technical documentation as set out in Annex II and III.
For sterile medical devices having measuring function or are reusable surgical instruments – should follow Annex I and II of Annex IX OR part A of Annex XI. In some cases, the involvement of the notified body is limited.
For custom-made devices – must follow procedures set out in Annex XIII and should create a statement set out in Sec. 1 of the same annex before placing the device in market.
For investigational devices- should follow the requirements in the articles 62 to 81.