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. In Denmark, there are more than 500,000 different types of devices many of which make a huge or even vital difference for those who need them.

If these devices start malfunctioning, fail or are used in the wrong way, the consequences could therefore be serious. That's 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 as it could have serious consequences for patients or healthcare professionals.

Healthcare professionals, manufacturers, authorised representatives, distributors and importers are obliged to report device malfunction, failure and deficiencies

Serious medical device incidents (malfunction, failure and deficiencies) must be reported by:

Manufacturers

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)

Authorised representatives

Authorised representatives must immediately report serious and suspected serious incidents to the manufacturer.

Importers

Importers must immediately report suspected serious and serious incidents to the manufacturer and any authorised representative.

Distributors

Distributors must immediately report serious and suspected serious incidents to the manufacturer and any authorised representative and importer.

Entities with operational responsibility for public and private hospitals and healthcare professionals

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 with the reporting duty such as risk managers and healthcare professionals.

Serious incidents can moreover be reported by:

Any other member of the public (users, patients, relatives, etc.) can report serious or suspected serious incidents to the competent authority, i.e. the Danish Medicines Agency in Denmark. You can submit a report using the form below. On receipt of the report, the Danish Medicines Agency sends the information to the manufacturer. The manufacturer will then also submit an incident report and will 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 have a duty to report adverse events to the Danish Patient Safety Authority. You can read more about adverse events here.