6 Meddev Solutions Limited (RAPS e-Book version)
Contents
Article 62: Requirements regarding clinical investigations 197
Article 63: Informed consent 200
Article 64: Clinical investigations on incapacitated subjects 201
Article 65: Clinical investigations on minors 202
Article 66: Investigations on pregnant/breastfeeding women 203
Article 67: Additional national measures 204
Article 68: Clinical investigations in emergency situations 205
Article 69: Damage compensation 207
Article 70: Application for clinical investigations 208
Article 71: Assessment by Member States 210
Article 72: Conduct of a clinical investigation 211
Article 73: Electronic system on clinical investigations 212
Article 74: Clinical investigations with CE marked devices 213
Article 75: Substantial modifications to clinical investigations 214
Article 76: Information exchange between Member States 215
Article 77: Information at the end of a clinical investigation 216
Article 78: Assessment procedure for clinical investigations 217
Article 79: Review of coordinated assessment procedure 218
Article 80: Adverse events during clinical investigations 219
Article 81: Implementing acts 220
Article 82: Requirements of other clinical investigations 221
Article 83: Post-market surveillance system of manufacturer 222
Article 84: Post-market surveillance plan 224
Article 85: Post-market surveillance report 225
Article 86: Periodic safety update report 226
Article 87: Incidents and field safety corrective actions 228
Article 88: Trend reporting 229
Article 89: Analysis of incidents &field safety corrective actions 230
Article 90: Analysis of vigilance data 231
Article 91: Implementing acts 232
Article 92: System on vigilance and post-market surveillance 233