Manufacturing and Distribution of Medical Devices
Only correctly CE marked medical devices may be placed on the Austrian market. Exemptions for CE-marking exist for devices for Clinical Investigations (Medical Devices) or Perfomance Evaluations (IVD) and for Custom Made Devices.
Affixing the CE mark the manufacturer declares that the device conforms to the essential requirements and therefore is technically and clinically safe and effective for the intended use. This is based on the Declaration of Conformity and the underlying Conformity Assessment.
The Conformity Assessment is done under the sole responsibility of the manufacturer. Applying the correct procedure the manufacturer provides documented evidence of the safety and efficacy of the device based on the technical documentation and the clinical evaluation including the positive risk-benefit-ratio of the device.
Before completing the procedure of conformity assessment the device shall NOT be placed on the market.
Manufacturer means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations (producing) are carried out by that person himself or on his behalf by a third party.
Name and address of the manufacturer shall be printed on the labeling and the accompanying information.
What kinds of Medical Devices exist?
Activ implantable Medical Devices (AIMD acc. to Directive 90/385/EEC)
Medical Devices (MD acc. to Directive 93/42/EEC)
- Class III
- Class IIb
- Class IIa
- Class I (Is, Im)
In-vitro-diagnostic Medical Devices (IVD acc. to Directive 98/79/EC)
- Annex II List A
- Annex II List B
- IVD for Home Use
- Common IVD
Created: 10.11.2014 | Page last modified: 27.01.2015