Report Clinical Trials for In Vitro Diagnostic Medical Devices Under IVDR

Find information on what you, as an applicant, need to be aware of when preparing applications for permission to conduct clinical trials of medical devices for in vitro diagnostics.

After 26 May 2022, medical equipment for in vitro diagnostics can only be put into use when these are CE marked. To obtain CE marking, the equipment must undergo a performance evaluation through clinical trials. These clinical trials are covered by the EU regulation on medical devices for in vitro diagnostics (2017/746/EU) and may not be initiated until a positive opinion is obtained from a scientific ethics medical committee.

The scientific ethics medical committee makes a scientific and ethical review of the case material. Emphasis is placed here on the fact that the clinical trials are designed and can be carried out in such a way that subjects are protected in terms of their rights, safety, dignity and welfare, which must come before all other interests, and that the data generated is scientifically substantiated , reliable and robust.

Clinical trials with medical devices for in vitro diagnostics that are not yet CE marked must meet the requirements described in Article 58 of the regulation, and clinical trials of already CE marked medical devices for in vitro diagnostics are regulated in Article 70 of the regulation.

It is thus the purpose of the test that defines what type of test it is and to which it must be reported.

Clinical trials of medical devices for in vitro diagnostics aimed at obtaining the CE marking or extending the CE marking (Article 58(1) and Article 70(2) of the Regulation)

In order for a clinical test of a medical device to be covered by the regulation's article 58, subsection 1 the following conditions must be met:

  • must include surgically invasive samples that are taken only for the purpose of studying performance and is an interventional clinical performance study, the test results of which may influence decisions about patient care and/or be used in treatment guidance,

or

  • conducting the study involves additional invasive interventions or other risks for the subjects of the studies compared to the standard procedure for using the equipment.

If the clinical testing of in vitro diagnostic medical equipment is carried out with a view to obtaining the CE mark for the equipment, it must be reported to both MREC and the Danish Medicines Agency.

If the clinical testing is carried out with CE-marked in vitro diagnostic medical equipment with use outside the equipment's stated purpose, the rules in Article 58 of the regulation apply. Such clinical trials that meet the conditions of Article 58 of the regulation,

  • subsection (1) must be reported to both MREC and the Danish Medicines Agency.
  • subsection (2) must only be notified to the Danish Medicines Agency, but with notification to the Danish Medicines Agency. PCS. 2 deals with clinical tests of equipment for accompanying diagnostics, i.e. equipment which is essential for the safe and effective use of an associated medicinal product.

For clinical tests of medical devices for in vitro diagnostics covered by the regulation's article 58(1) and article 70(2), the following application form must be used. The application form must be submitted simultaneously with the application's other documents via e-mail to both the Danish Medicines Agency and MREC:

Application form Article 58 and 70(2)

Clinical trials of medical devices for in vitro diagnostics used within CE marking - clinical follow-up studies (Article 70(1) of the Regulation)

If, after marketing, clinical follow-up studies of CE-marked in vitro diagnostic medical devices are carried out, these must be reported to MREC. If these tests imply that the trial participants are exposed to additional procedures than those during normal use of the equipment, and are invasive or burdensome, the Danish Medicines Agency must also be notified of this.

If you are in doubt as to whether the test involves additional burdensome or invasive procedures, contact MREC by e-mail: kontakt@dvmk.dk.

For clinical trials according to Article 70(1), the following application form must be used and sent by e-mail only to MREC:

Application form art. 70(1)

The processing time for applications is 45 days from the application being declared valid.

Doubts about the obligation to report?

If you are unsure whether your project is subject to report to MREC or not, you can contact us by email. In the email, you must write in the subject field: Inquiry about the obligation to report. In the email, you either attach a synopsis or protocol (preferably pdf.) that describes the following:

  • Project title
  • The background of the project,
  • The purpose of the project,
  • The project's design method; if it is an experiment with medical equipment, we would like to know whether it is CE marked or not
  • Description of potential trial participants
  • What is measured (endpoints).

The email must be sent to kontakt@dvmk.dk . We will then assess whether you should report or not and return with an answer as soon as possible.

Applications are sent to dketik@dketik.dk or via secure email - see information about this on our contact page .

Doubts about whether equipment being in vitro diagnostic medical equipment?

In case of doubt as to whether the equipment is an in vitro diagnostic medical device or not, the Danish Medicines Agency has the competence to assess this. Contact via med-udstyr@dkma.dk

Should you also apply to The Danish Medicines Agency?

According to the EU regulation on medical devices for in vitro diagnostics (2017/746/EU), which entered into force on 26 May 2022, must:

  • Permission for studies of the performance of medical equipment for in vitro diagnostics covered by Article 58 of the regulation is sought from both the Danish Medicines Agency and the Danish Medicines Agency.
  • Permission to carry out studies on the performance of medical devices for in vitro diagnostics covered by the regulation's article 70, paragraph 1 is sought at MREC. 

Did you know that

  • Clinical trials with medical devices for in vitro diagnostics notified before 26 May 2022 to a regional scientific ethics committee are finalized by this committee.
  • Additional protocols for clinical trials with medical devices for in vitro diagnostics, which have been approved by a regional scientific ethics committee before 26 May 2022, will continue to be processed by the approving regional committee.
Last updated 07-03-2024

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