8 Meddev Solutions Limited (RAPS e-Book version)
Contents
CHAPTER 11 269
MDR Overview -Annexes 269
ANNEX I -General Safety &Performance Requirements 270
ANNEX II -Technical Documentation 324
ANNEX III -Post-Market Surveillance 327
A quick PMS Checklist: 329
ANNEX IV -Declaration Of Conformity 330
ANNEX V -CE Marking of Conformity 332
ANNEX VI -UDI 334
ANNEX VII -Requirements to be met by Notified Bodies 338
ANNEX VIII -Classification Rules 341
ANNEX IX -Conformity Assessment based on a QMS 346
ANNEX X -Conformity Assessment -Type Examination 349
ANNEX XI -Conformity Assessment -Product Verification 351
ANNEX XII -Certificates issued by a Notified Body 354
ANNEX XIII -Procedure for Custom-Made Devices 356
ANNEX XIV -Clinical Evaluation and PMCF 358
ANNEX XV -Clinical Investigations 360
ANNEX XVI -Products without a Medical Purpose 362
ANNEX XVII -Correlation Table 363
CHAPTER 12 365
Indexes &Look Ups 365
Acronyms 365
List of regulations and Directives 367
Delegating Acts 369
Implementing Acts 370
CHAPTER 13 375
People 375