Notification - medical devices
Danish Standards/DGM has been notified by the Danish Ministry of the Interior and Health to approve medical devices in accordance with all Annexes of Council Directive 93/42/EEC, i.e.:
- Annex II - Full Quality Assurance
- Annex III - EC Type-Examination
- Annex IV - EC Verification
- Annex V - Production Quality Assurance
- Annex VI - Product Quality Assurance
- Annex II, section 4 - EC Design-Examination
By virtue of the broad expertise available among the founders, Danish Standards/DGM has been notified to approve a large range of active and non-active medical devices.
Active medical devices include all medical devices depending on a source of energy to be able to operate. Non-active medical devices include all other medical devices not covered by the above definition, e.g. utensils and implants. Below you will find a survey of the products covered by Danish Standards/DGM's notification.
Active medical devices
- suction equipment
- dental equipment
- hearing aids and audiometers
- electrocardiographs and electroencephalographs
- sterilizers for medical devices
- ultrasound equipment
- X-ray equipment
- CT scanners
- patient monitoring equipment
- equipment for registration of life-supporting functions
- defibrillators
- blood gas analyzers and anaesthetic monitors
- electrosurgical equipment
- surgical lasers
- heart-lung machines
- equipment for planning radiation therapy
- software for planning radiation therapy
- equipment for stimulators
- neonatal equipment
Non-active medical devices
- infusion equipment incl. accessories
- bandages and wound dressing materials
- drains, probes and suction equipment
- surgical equipment
- dental materials
- dental implants
- disinfectants
- sutures and adhesives
- contact lens fluids
- contraceptive devices
- surgical implants (excluding orthopedical implants and bone cement)
- single use devices
- cardiovascular implants
- contact lenses
- medical devices for in vitro fertilization
Medical devices are divided into 4 risk classes, i.e. classes I, IIa, IIb og III. Further, class I devices are subdivided in class Im and class Is, where m refers to devices with a measuring function and s refers to devices which are marketed in a sterile condition. The classification of a product reflects the risk associated with its use, the vulnerability of the part of the human body where the product is applied and the period of time for which the product is used.
Danish Standards/DGM has been notified to approve products within all risk classes.
Danish Standards/DGM is accredited as European CAB (Conformity Assessment Body) under MRA (Mutual Recognition Agreements) together with USA, Canada, Australia, and New Zealand.
Danish Standards/DGM is appointed by the FDA as AP (Accredited Person). An AP is a third party who on behalf on the FDA is authorized to carry out audits of quality systems for manufacturers of medical devices. An inspection carried out by an AP is an alternative to the traditional FDA inspection. It is thus up to the individual manufacturer to choose between an AP inspection or an FDA inspection.
It is DGM's mission to:
- approve medical devices and quality systems in accordance with national and international regulatory requirements and standards
- offer value-adding services and courses globally within the field of our key competences
- be a world-class collaborator
- develop services permanently meeting the clients' requirements
- attract and maintain competent employees
