DGM Guidelines
DGM Guideline "Computers, assessment of conformity to the MDD", version 1.0
Assessing systems consisting of proprietary hardware in combination with commercially available computer systems intended for processing patient data can constitute a difficult task with respect to the requirements found in the Medical Devices Directive (MDD)(93/42/EEC).
This paper draws the attention of the manufacturer to certain important definitions in the Directive and explains the options available to him and their consequences. Size: 76 KB.
DGM Guideline "EC declaration of conformity, drawing up the right declarations before placing the medical device on the market", version 1.1
This document applies to the requirements of the manufacturer to draw up a written Declaration of Conformity (DoC) that declares that the products concerned meet all the provisions of the Medical Devices Directive that apply to them. Size: 61 KB.
DGM Guideline "EN 60601-1-4, requirements for programmable medical systems, mapped into the EN ISO 9001", version 1.2
The aim of this DGM guideline is to assist the manufacturers who already have an EN ISO 9001/EN 46001 compliant Quality Systems to locate available quality system documents which may be reused to demonstrate compliance to harmonized standard EN 60601-1-4 "Risk analysis of software for medical devices".
By using this mapping the manufacturer is eased in demonstrating compliance to the relevant requirement in the Medical Devices Directive (MDD) 93/42/EEC
Siza: 51 KB.
DGM Guideline "In Vitro Diagnostic Devices Directive, understanding the requirements", version 2.2
This document applies to manufacturers of In Vitro Diagnostic medical devices and can be considered as a background note for understanding the impact of this new EC Directive. It also represents the current thinking of the Danish Notified Body, DGM with respect to the interpretation of the IVD Directive.
We recommend the reader to study this pamphlet to get a first understanding of the IVD Directive (IVDD) and then to move on to read the Directive itself. Size: 31 KB.
DGM Guideline "Own-Brand labeller, relationship between OEM and OBL", version 2.2
The aim of this DGM guideline is to assist the manufacturers to get an overview of the requirement for building a relationship between an Original Equipment Manufacturer (OEM) and an Own-Brand Labeller (OBL). The requirements to a quality system of the OBL are also discussed. Size: 87 KB.
DGM Guideline "Preparation of documentation files to be submitted to NB for conformity assessment with view to CE Marking", version 3.1
To assist manufacturers with an overview of the required types of documentation.
Manufacturers must, as part of their application to the Notified Body (NB), include sufficient documentary evidence to prove conformity with all the general requirements of the Medical Devices Directive (MDD) 93/42/EEC and the particular requirements defined in the selected Annexes for which they are applying for approval.SIze: 100 KB.
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