Reporting of incidents: Reporting of medical device malfunction, failure, and deficiencies
Medical devices could be anything from crutches, wheelchairs and glasses to diagnostic analyses, pacemakers, mobile phone apps and state-of-the-art surgical devices and appliances used in hospitals. If these devices start malfunctioning, fail or are used in the wrong way, the consequences can be serious to the patients, healthcare professionals or others. That is why it is important that manufacturers and authorities are informed if a medical device does not work as intended or if errors or other problems occur.
Manufacturers, healthcare professionals, and entities with operational responsibility for public and private hospitals are obliged to report serious incidents or suspected serious incidents (device malfunction, failure and deficiencies) to the competent authority, i.e. the Danish Medicines Agency in Denmark.
Others e.g., users, patients, authorised representatives, distributors, and importers also have the possibility to report incidents to the Danish Medicines Agency.
Obligation to report and possibility to report
- Manufacturers are required within the applicable deadlines to report serious incidents to the relevant competent authority; in Denmark this is the Danish Medicines Agency (see https://www.retsinformation.dk/eli/retsinfo/2021/9363). See guidance for manufacturers regarding incident reporting and field safety corrective actions here.
- Healthcare professionals and entities with operational responsibility for public and private hospitals: Entities with operational responsibility for public and private hospitals are obliged to immediately report serious and suspected serious incidents to the Danish Medicines Agency. Healthcare professionals pursuing activities as a self-employed person outside the health services are also obliged to report serious and suspected serious incidents to the Danish Medicines Agency (see the executive order on medical devices etc.). In practice, those with operational responsibility may lay down local guidelines establishing who is responsible for compliance regarding the reporting obligations, such as risk managers or healthcare professionals.
- Any other citizen (users, patients, relatives, etc.) can report suspected serious incidents to the Danish Medicines Agency.
- Authorised representatives must immediately report suspected serious incidents to the manufacturer and have the possibility to report suspected serious incidents to the Danish Medicines Agency.
- Importers must immediately report suspected serious incidents to the manufacturer and any authorised representative. Importers have the possibility to report suspected serious incidents to the Danish Medicines Agency.
- Distributors must immediately report suspected serious incidents to the manufacturer and any authorised representative and importer. Distributors have the possibility to report suspected serious incidents to the Danish Medicines Agency.
When receiving a report from healthcare professionals, users, patients or relatives, the Danish Medicines Agency sends the information to the manufacturer. The manufacturer will then investigate the serious incident.
At the Danish Medicines Agency, we review all reports to determine if the manufacturer should make changes to the device or 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.
Was the incident also an adverse event?
If the answer is yes, it must be reported to the Danish Patient Safety Authority pursuant to section 198(2) of the Danish Health Act. The Danish Patient Safety Authority then investigates if the healthcare services can learn from the event. Doctors, nurses, dentists and other healthcare professionals are obliged to report adverse events to the Danish Patient Safety Authority. You can read more about adverse events here.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
Denmark
CVR no.: 37052485
Telephone: +45 44 88 95 95
Email: Send an email
Do you have any questions?
If you have questions about our processing of your data, we advise you to contact our data protection officer.
Our data protection officer can be contacted in the following ways:
- Email: Send an email
Letter:
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:
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The Danish Medicines Agency has regulatory responsibility for safety monitoring and market surveillance of medical devices in Denmark.
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The Danish Medicines Agency uses the incident reports in our work of monitoring the safety of medical devices.
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The report received by the Danish Medicines Agency is registered in our records system.
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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 any deficiencies affecting the safety or performance of the device. If changes need to be implemented, we ensure that it happens. For example, it may be necessary to change the information in the instructions for use, or to make alterations to the device for its safe and proper use.
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Your report will be forwarded to the medical device manufacturer.
The legal basis for our processing of your personal data follows from:
Danish Act on Medical Devices with related executive orders (executive order on medical devices and products without an intended medical purpose, executive order on in vitro diagnostic medical devices), and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.
(Please note that the Danish executive orders linked above are not available in English; their titles have been translated for ease of understanding)
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 in 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 an archival period (usually five years).
Your rights
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.