Reporting of incidents and accidents with medical devices
Medical devices could be anything from crutches to surgical instruments used in hospitals. In Denmark, there are more than 500,000 different types of devices that are of substantial benefit or even vital importance to many medical device users.
If, on the other hand, the devices start malfunctioning or are used in the wrong way, the consequences could be serious. And for this reason, it is important that the authorities are informed if a medical device does not work as intended or if errors or other problems occur as the consequences for patients or healthcare professionals could be serious.
Healthcare professionals and manufacturers have a duty to report malfunction, failure or deficiencies
Doctors, nurses, dentists, other healthcare professionals and manufacturers have a duty to report it to the Danish Medicines Agency if they suspect a medical device malfunction, failure or deficiency.
Members of the general public can also make a report if they discover a medical device malfunction via the link below.
At the Danish Medicines Agency, we review all reports to determine if the manufacturer should make changes to the device, update the instructions for use or if, in the last resort, the device should be recalled from the market.
We collaborate in this matter with the authorities of other countries, including those in the EU.
Healthcare professionals must also submit a report to the Danish Patient Safety Authority
Besides reporting device malfunction, failure and deficiencies to the Danish Medicines Agency, doctors, nurses, dentists and other healthcare professionals must also report the case as an adverse incident to the Danish Patient Safety Authority. The Danish Patient Safety Authority then investigates if the healthcare services can learn from the incident
Healthcare professionals' reporting of incidents with medical devices (in Danish, opens in a new window)
Users’ reporting of incidents with medical devices (opens up in a new window)
We are the data controller - how to contact us
The Danish Medicines Agency is the data controller in respect of the processing of the personal data we have received from you. Please find our contact details below.
Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
CVR no.: 37052485
Telephone: +45 44 88 95 95
Contact details of the Data Protection Officer
If you have questions about our processing of your data, we advise you to contact our data protection officer.
Our data protection officer, Troels Mogensen, can be contacted in the following ways:
- Email: email@example.com
The Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
Att. ”data protection officer"
The purposes and the legal basis of the processing of your personal data
We process your personal data for the following purposes:
- The Danish Medicines Agency has regulatory responsibility for safety monitoring and market surveillance of medical devices in Denmark.
- The Danish Medicines Agency uses the incident reports in our work with the monitoring of the safety of medical devices.
- The report that is received by the Danish Medicines Agency is registered in our records system.
- We contact the medical device manufacturer (if the manufacturer can be identified) to clarify the cause of the incident. The manufacturer will start an investigation to find out if there are defects affecting the safety or performance of the device. If changes need to be implemented, we ensure that it happens. It could for example be necessary to change the information in the instructions for use, or make changes to the device so that it can be used safely and correctly.
- Your report will be forwarded to the medical device manufacturer. [CPR (civil registration) numbers of patients/users will not be forwarded to the manufacturer]
The legal basis for our processing of your personal data follows from:
Act No. 1046 of 17 December 2002 concerning medical devices (in Danish) and appertaining Danish Executive Orders (not available in English: Executive Order on medical devices, Executive Order on active implantable medical devices, Executive Order on medical devices for in vitro diagnosis).
Categories of personal data
We process the following categories of personal data about you:
- Basic information, such as name and contact details.
Recipients or categories of recipients
We disclose or transfer your personal data to the following recipients:
- The Danish Medicines Agency sends the report to the medical device manufacturer (if the manufacturer can be identified).
Storing of your personal data
We use the incident reports for our work with the continuous monitoring of the safety of medical devices. For this purpose, we store your information for a period of 20 years after the expiry of a journal period (usually 5 years).
The General Data Protection Regulation gives you a number of rights in respect of our processing of your personal data.
If you want to make use of your rights, you need to contact us.
Right to see your data (right of access)
You have the right to access the information we process about you as well as other information.
Right to rectification (correction)
You have the right to have incorrect information about you corrected.
Right to erasure
In exceptional cases, you have the right to have information about you erased before the time we would generally erase the information.
Right to restriction of processing
In certain cases, you have the right to have the processing of your data restricted. If you do have the right to restriction of processing, then we are only allowed to process your data, with the exception of storage, with your consent or for the establishment, exercise or defence of legal claims or for the protection of the rights of another person or for reasons of important public interest.
Right to object
In certain cases, you have the right to object to our otherwise legal processing of your personal data.
You can read more about your rights in the Danish Data Protection Agency's guidelines on the rights of data subjects. The guidelines are available in Danish at the website of the Danish Data Protection Agency: www.datatilsynet.dk
Lodging a complaint with the Danish Data Protection Agency
You have the right to lodge a complaint with the Danish Data Protection Agency if you are displeased with the way in which we process your personal data. The contact details of the Danish Data Protection Agency are available at www.datatilsynet.dk.