Performance studies of in vitro diagnostic medical devices (IVDs)
In the case of certain performance studies of in vitro diagnostic medical device, the sponsor must submit an application to the Danish Medicines Agency before the study may commence.
The performance studies comprised by the provisions of Article 58 of the regulation on in vitro diagnostic medical devices (IVDR) requiring the submission of an application before the study can take place include any performance study in which:
- surgically invasive sample-taking is done only for the purpose of the performance study (Article 58(1)(a) of the IVDR), or
- the test result from the in vitro diagnostic medical device (currently subject to the performance study) may influence patient management decisions and/or may be used to guide treatment (Article 58(1)(b) of the IVDR), or
- the conduct of the performance study of the in vitro diagnostic medical device involves additional invasive procedures or other risks for the subjects of the study (from whom the sample material is to be taken/comes from) (Article 58(1)(c) of the IVDR).
Performance studies involving companion diagnostics are subject to the same requirements that apply to the above-mentioned performance studies. Performance studies involving companion diagnostics using only left-over samples are excluded from this, however, must be notified to the Danish Medicines Agency (see below).
If the performance study of an in vitro diagnostic medical device meets all of the above-mentioned criteria, the sponsor of the study must submit an application for authorisation to the Danish Medicines Agency.
Performance studies subject to notification to the Danish Medicines Agency
If in Denmark a performance study is to be conducted of an in vitro diagnostic medical device which already bears the CE marking and is used within the scope of the CE marking, but the research participants are submitted to additional invasive or burdensome procedures, the Danish Medicines Agency must be notified of the study 30 days prior to its commencement. This is done by sending an email with a short description of the study, attaching a positive opinion, if any, from the Medical Research Ethics Committees.
Performance study of a non-CE marked companion diagnostic using only left-over samples and where the study does not involve an intervention
The conduct in Denmark of a performance study of a non-CE marked companion diagnostic that uses only left-over samples and where the study involves no intervention for the research participant having given the sample must be notified to the Danish Medicines Agency. This is done by sending an email with a short description of the study. The description shall include:
| Topic | Notification of performance study involving companion diagnostics using only left-over samples (IVDR Art. 58(2)) |
| Performance study sponsor details | Company name, contact name, company address, phone number and e-mail |
| If relevant, please specify Danish performance study analysis site(s) | Site name(s), site contact name(s), site address, phone number and e-mail |
| Device manufacturer | Company name, contact name, company address, phone number and e-mail |
| Device description | Device/product name and device/product type |
| Corresponding medicinal product | Brand name and generic name |
| Performance study | Sponsor's performance study plan code/number and study title |
| Use of results - assurance from sponsor | Sponsor's confirmation that results from the performance study has no impact/intervention on treatment of patients in Denmark and that the conduct of the study involves no additional invasive procedures or other risks for the subject of the study in Denmark |
International standard for performance studies of in vitro diagnostic medical devices available from Danish Standards.
The DS/ISO 20916:2019 standard ”In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice” is available from Danish Standards and can be purchased at https://webshop.ds.dk/.