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MDR - Medical Device Regulation article

MDR Article 87

Article 87 Reporting of serious incidents and field safety corrective actions 1. Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7),

MDR - Medical Device Regulation article

MDR Article 32

Article 32 Summary of safety and clinical performance 1. For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance. The summary of safety

MDR - Medical Device Regulation article

MDR Article 15

Article 15 Person responsible for regulatory compliance 1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be

MDR - Medical Device Regulation article

MDR Article 22

Article 22 Systems and procedure packs 1. Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the

MDR - Medical Device Regulation article

MDR Article 120

Article 120 Transitional provisions 1. From 26 May 2020, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void. 2. Certificates issued by notified bodies in accordance with

MDR - Medical Device Regulation article

MDR Article 18

Article 18 Implant card and information to be supplied to the patient with an implanted device 1. The manufacturer of an implantable device shall provide together with the device the following: (a) information allowing the identification of the device,

MDR - Medical Device Regulation article

MDR Article 27

Article 27 Unique Device Identification system 1. 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 shall

MDR - Medical Device Regulation article

MDR ANNEX XVI

ANNEX XVI LIST 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

MDR - Medical Device Regulation article

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 shall

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