The Medical Devices Introductory Course 2020

Class IIb Implants Article 52.4 - New

“However, 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 . ”

• Same as for class III devices

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

11

Class IIa (MDR Article 52.6)

Device category MDD Art 1.2(l): Set of devices having common areas of intended use or common technology

Annex IX Ch II, S4 Technical Documentation Every device category

Annexes II & III Technical Documentation Every device category

Annex XI – Part B, S18 Product Verification

Annex IX Ch 1 & Ch III QMS / Admin

Annex XI – Part A, S10 Production Quality Assurance

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

1234

The Organisation for Professionals in Regulatory Affairs

12