Distributors' and importers' reporting

Updated 17 January 2020

Distributors and importers have an obligation to report serious incidents and accidents with medical devices to the Danish Medicines Agency. The manufacturer should also be informed of the incident with the relevant device. Please use the below form to report the incident.

Incident reporting    

Please report incidents in the following form:

New Manufacturer's Incident Report

Please notice that this is a new version of the manufacturer's incident report form. The new form is valid from 1. January 2020.

Guidelines

Guidelines on manufacturers' reporting of incidents with medical devices

Please send the reporting form to Medical Devices:

Email: Send an email
Fax: +45 44 88 95 99
Letter:
Danish Medicines Agency/Medical Devices
Axel Heides Gade 1
DK-2300 Copenhagen S

Reporting form

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

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:

The Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
Att. ”data protection officer"

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).

We process the following categories of personal data about you:

  • Basic information, such as name and contact details.

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).

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

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.

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