MDR Article 18

MDR Article 18

Article 18 Implant card and information to be supplied to the patient with an implanted device1. The manufacturer of an implantable device shall provide together with the device the following:(a) information allowing the identification of the device, including the...
MDR Article 18

MDR Article 27

Article 27Unique Device Identification system1. The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and...
MDR Article 18

MDR ANNEX XVI

ANNEX XVILIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)1. Contact lenses or other items intended to be introduced into or onto the eye.2. Products intended to be totally or partially introduced into the human body through...
MDR Article 18

MDR Article 10

Article 10General obligations of manufacturers 1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.2. Manufacturers...