4 Meddev Solutions Limited (RAPS e-Book version)
Contents
CHAPTER 10 105
MDR Overview -Articles 105
Article 1: Subject Matter and Scope 106
Article 2: Definitions 108
Article 3: Amendment of certain definitions 110
Article 4: Regulatory status of products 111
Article 5: Placing on the market &putting into service 112
Article 6: Distance sales 114
Article 7: Claims 115
Article 8: Use of harmonised standards 116
Article 9: Common specifications 118
Article 10: General obligations of manufacturers 120
Article 11: Authorised representative 125
Article 12: Change of authorised representative 127
Article 13: General obligations of importers 128
Article 14: General obligations of distributors 129
Article 15: Person responsible for regulatory compliance 130
Article 16: When Manufacturer obligations apply to others 132
Article 17: Single-use devices and their reprocessing 134
Article 18: Implant card and information to be supplied 135
Article 19: EU declaration of conformity 136
Article 20: CE marking of conformity 138
Article 21: Devices for special purposes 139
Article 22: Systems and procedure packs 141
Article 23: Parts and components 143
Article 24: Free movement 144
Article 25: Identification within the supply chain 145
Article 26: Medical devices nomenclature 147
Article 27: Unique Device Identification system 148
Article 28: UDI database 150
Article 29: Registration of devices 151
Article 30: System for registration of economic operators 153