Annex II – Technical documentation
Annex III – Technical documentation on post-market surveillance
Annex IX – Conformity assessment based on a quality management system and assessment of the technical documentation
Annex X – Conformity assessment based on type examination
Annex XI – Conformity assessment based on product conformity verification – Part A: Production Quality Assurance
Annex XI – Conformity assessment based on product conformity verification – Part B: Product Verification
Annex XIII – Procedure for Custom-Made Devices