About Medical Devices
Medical devices cover many products which are used in different healthcare settings:
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Incident reporting
Adverse events/serious incidents that occur with the use of any medical device must be reported to the Danish Health and Medicines Authority.
20 November 2012 /News - medical devices
21 December is final date for submission of clinical investigation applications in 2012
The Danish Health and Medicines Authority is closed between Christmas and New Year. Therefore, applications for authorisation of clinical investigations in 2012 must be received by 21 December 2012. Applications received after this date will be considered received on 2 January 2013.
26 October 2012 /News - medical devices
Criticism of CE marking of medical devices in Czech Republic and Slovakia
In cooperation with the British Medical Journal, the Daily Telegraph reported today that two named notified bodies in the Czech Republic and Slovakia do not comply with EU medical devices law. It appears from the articles that companies can have their medical devices certified by the notified bodies based on a hasty and superficial evaluation. It is also claimed that companies can have products certified that resemble products which have been removed from the market because of safety problems.