5 Meddev Solutions Limited (RAPS e-Book version)
Contents
Article 31: Registration of Economic Operators 155
Article 32: Summary of safety and clinical performance 157
Article 33: European database on medical devices 159
Article 34: Functionality of Eudamed 161
Article 35: Authorities responsible for notified bodies 162
Article 36: Requirements relating to notified bodies 164
Article 37: Subsidiaries and subcontracting 165
Article 38: Application by CABs for designation 166
Article 39: Assessment of the application 167
Article 40: Assessment of applications for notification 169
Article 41: Language requirements 171
Article 42: Designation and notification procedure 173
Article 43: Identification number and list of notified bodies 174
Article 44: Monitoring and re-assessment of notified bodies 175
Article 45: Review of notified body assessment 176
Article 46: Changes to designations and notifications 177
Article 47: Challenge to the competence of notified bodies 178
Article 48: Exchange of experience between authorities 179
Article 49: Coordination of notified bodies 180
Article 50: List of standard fees 181
Article 51: Classification of devices 182
Article 52: Conformity assessment procedures 184
Article 53: Notified bodies in conformity assessment 186
Article 54: Clinical evaluation consultation procedure 187
Article 55: Mechanism for scrutiny of conformity assessments 189
Article 56: Certificates of conformity 190
Article 57: System on NBs and certificates of conformity 191
Article 58: Voluntary change of notified body 192
Article 59: Derogation from conformity assessment 193
Article 60: Certificate of free sale 194
Article 61: Clinical evaluation 195