The Medical Devices Introductory Course 2020

Conformity Assessment Article 52 (MDD Article 11)

“Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI .” • Specifies the applicable conformity assessment options for each product class • States that for all product classes except for class I there is a choice of possible options • States that the M may choose his option • Hint: see the handout provided.

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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Conformity Assessment Procedures

Annex IX:

“Conformity assessment based on a QMS and on assessment of technical documentation” This QMS is a full QMS including design

Annex X:

“Conformity assessment based on type examination”

Annex XI:

“Conformity assessment based on product conformity verification ( Part A: Production quality assurance. Part

B:

Product verification )” Part A = QMS for Production (not Design) Part B = Batch testing

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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