The Medical Devices Introductory Course 2020

Class IIb Article 52.4 (MDD Article 11.3)

“Manufacturers … shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group . Alternatively , the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI.” • Same as for class III devices except that the technical documentation is assessed on a representative basis only

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

9

Class IIb (MDR Article 52.4)

Generic device group MDR Art 2(7): Set of devices having the same or similar intended purposes or a commonality of technology

Annex IX Ch I & Ch III QMS / Admin Annex IX Ch II, S4 Technical Documentation Every generic device group

Annex X Type Examination inc Technical Documentation

Annex XI – Part A Production Quality Assurance

Annex XI – Part B Product Verification

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

1234

The Organisation for Professionals in Regulatory Affairs

10