Requirements for clinical trials and testing of medical devices and drugs

Medical Research Ethics Committees (MREC)

You need to apply for an approval at one of the MREC’s if your research project involves clinical trials of medicinal products, medical device trials, in vitro diagnostic devices, and testing of medical devices and drugs (involving humans/human tissue), including:

Health scientific research projects in humans involving drugs
Trials of medical equipment aimed at obtaining or extending CE marking
Trials of CE-marked medical equipment post-market – clinical follow-up studies
Trials of medical equipment for other purposes
Health scientific research projects involving in vitro diagnostic devices (IVD)
Cluster trials

Trials involving drugs should be submitted via CTIS (Clinical Trials Information System).

For health scientific research projects that concern in-vitro diagnostic equipment, you must contact MREC.

Danish Medicines Agency (DMA)

Approval from the DMA may be necessary for clinical trials involving testing devices and drugs. Clinical trials may include participation from healthy individuals or patients. If your research project involves human subjects, and its purpose is to investigate the effect, side effects, efficacy, or influence of a drug or device, it qualifies as a clinical trial according to the DMA's definition. In such cases, approval from the DMA is required in addition to approval from either the National Ethics Committee (NEC) or the Regional Ethics Committee (REC). Read more about approvals from NEC or REC.

If uncertain, please visit the Guide to assessing if a trial falls under the definition of a clinical trial (laegemiddelstyrelsen.dk)

Exemptions not requiring ethics approval from the DMA:

if your subjects are non-randomized volunteers
low intervention clinical trials (please see description below)

Low-intervention clinical trials

Danish legislation refers to low-intervention clinical trials as ‘non-intervention investigations’, defined in the Order that regulates Good Clinical Practice for Clinical Trials of Drugs in Humans (in Danish):

§ 2, stk. 5 i Bekendtgørelse om god klinisk praksis i forbindelse med kliniske forsøg med lægemidler på mennesker:

”En undersøgelse, hvor lægemidlet eller lægemidlerne ordineres som normal i overensstemmelse med betingelserne i markedsføringstilladelsen. Beslutningen om at ordinere det pågældende lægemiddel er klart adskilt fra beslutningen om at inkludere patienten i undersøgelsen. Selve behandlingen sker ikke i henhold til en forsøgsprotokol, men følger almindelig praksis. Der foretages ingen ekstra diagnostiske eller kontrolmæssige procedurer, og der skal anvendes epidemiologiske metoder til at analysere de indsamlede data.”

Low-intervention clinical trials are studies where the investigated medical products are already authorized for marketing. The following must also apply:

the investigational medicinal products are used in accordance with the terms of the marketing authorization or
the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products.

You must submit your low-intervention clinical trial in the EU CTIS (Clinical Trials Information System) database.

Contact

Ditte Rytter Peasah Krofa