Certificate of exemption within the meaning of § 32 (1) Medical Devices Act
The Austrian Federal Office for Safety in Health Care (“Bundesamt für Sicherheit im Gesundheitswesen”) may authorize, on duly justified request, the placing on the market and putting into service of individual medical devices for which the conformity assessment procedure and CE marking have not been carried out, within the Austrian territory.
A certificate of exemption may only be granted, if the use of the individual medical device is necessary in the interest of protection of health and if there is a lack of equivalent medical devices for which the conformity assessment procedure and CE marking have already been successfully completed. The certificate of exemption can be limited by time or by conditions of use.
Requests for certificate of exemption shall contain the following information:
- The exact name and intended use of the required medical device including any accessory.
- Rationale why and under which circumstances the use of the medical device is necessary in the interest of protection of health.
- Confirmation that equivalent medical devices for which the conformity assessment procedure and CE marking have already been successfully completed are not available.
- Confirmation that the applicable Essential Requirements concerning the purpose of the medical device are met. If some Essential Requirements are not fully met, a detailed benefit-risk-evaluation, showing that the use of the medical device is indicated despite some Essential Requirements not being met. In this case it must also be shown that all appropriate measures for the protection of patients, end-users and where appropriate other persons were taken.
- Declaration of the intended use and conditions of use of the product (intended use, indication, type and number of patients, healthcare facilities, special precautions for use, duration of use).
- For requests for renewal or extension of certificate of exemption, documents referring to points 2 to 4, providing evidence that the use of the medical device is still necessary in the interest of protection of health.
A certificate of exemption is not necessary if a medical doctor, qualified to practice in Austria, confirming that the medical device is necessary to prevent death or serious deterioration in state of health of a specific patient and that successful treatment is unlikely to be achieved with a medical device for which the conformity assessment procedure and CE marking have already been successfully completed (“medical confirmation”). In case of a planned usage of such medical device in a hospital, the “medical confirmation” shall be presented to the medical director of the health care unit (hospital) in advance.
Certificate of exemption for joint replacements:
With the implementation of the Austrian regulation for classification of medical devices, BGBl. II Nr. 136/2007, on September 1, 2007 (replaced by BGBl. II Nr. 143/2009 on March 21, 2010), implementing the Commission Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements. The first placing on the market of joint replacements for hip, knee and shoulder as class IIb medical devices is no longer legal.
Some joint replacements are no longer being placed on the market by their manufacturers and therefore these specific joint replacements have not undergone the necessary conformity assessment procedure for class III medical devices (no reclassification as class III medical devices).
In case of (partial) revisions of joint replacements not reclassified as class III medical devices (individual system components, e.g. revision of inlays), it can be advised in the interest of protection of health, to use the same components as originally implanted. In such cases the already implanted system and the component to be replaced, represent a functional unit without the possibility to use other already reclassified class III components of the same manufacturer or components of other manufacturers. In such cases it may be medically irresponsible and highly unethical to expose patients to the risk of a total joint replacement.
Information: Please be aware of the currently valid schedule of fees (Gebührentarif). Our hourly rate for processing certificates of exemption is 150 €.
Further information (partly in German)
Created: 12.11.2014 | Page last modified: 02.02.2016