The Medical Devices Introductory Course 2020

Class III Article 52.3 (MDD Article 11.1)

“Manufacturers … shall be subject to a conformity assessment as specified in Annex IX . Alternatively , the manufacturer may choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI .”

• The technical documentation must be assessed for every device

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

7

Class III Device (MDR Article 52.3)

Annex IX Ch II Technical Documentation Every device

Annex X Type Examination inc Technical Documentation

Annex XI – Part B Product Verification

Annex XI – Part A Production Quality Assurance

Annex IX Ch I & Ch III QMS / Admin

Declaration of Conformity (Annex IV) & CE Marking (Annex V)

The Organisation for Professionals in Regulatory Affairs

8