Clinical investigations for medical devices

The MPA oversees clinical investigations of medical devices in Sweden.

When a medical device is CE marked, this means a declaration by the manufacturer that the device performs as indicated by the manufacturer and the device's clinical benefits are not in disproportion to its side effects when used for its intended purpose and in the prescribed manner.

The supporting documentation for this declaration must include a clinical evaluation. The evaluation must be based on clinical data (see below) that can be retrieved from the relevant scientific literature and/or clinical investigations.

Clinical investigations are only to be performed when the information necessary on the performance, safety, and clinical benefit of the device cannot be obtained in any way other than by testing the device on humans. At the same time, it may be necessary for a clinical investigation regardless of the risk classification of the device.

If there is any doubt about whether the investigation/performance needs to be notified, the MPA can be consulted.

Clinical data

A manufacturer must be able to demonstrate that the devices placed on the market are safe and have the properties listed for the device, or in other materials provided by the manufacturer. This also applies to claims made in sales materials and pledges made by representatives/sellers. This responsibility is detailed in Section 5 of the Act (1993:584) on medical devices.

Section 5 A medical device must be suitable for its intended use. The device is suitable when it:

  1. is correctly delivered and installed, and maintained and used in accordance with the manufacturer's labelling, instructions or marketing, and
  2. achieves the performance intended by the manufacturer and meets the high requirements for the protection of the lives, personal safety and the health of patients, users and others.

This is further elaborated in the regulations that the MPA has issued in connection with the Act on medical devices. See Appendix 1 about the essential requirements of the MPA regulations (LVFS 2003:11) on medical devices in particular paragraphs 1, 3, 4, 5 and 6, and Appendix 1 of the MPA regulations (LVFS 2001:5) on active implantable medical devices, in particular paragraphs 1, 2, 3, 4 and 5.

In order to meet these requirements, the manufacturer must have sound knowledge of how the device will work in practical use, i.e. the manufacturer must have knowledge of the device's characteristics and actual performance. In particular, the manufacturer must know what unwanted side effects the device might cause. This also applies even if these side effects only affect a minority of the intended user group.

This knowledge is termed “clinical data” and serves as important supporting documentation for the clinical evaluation that will provide answers to the question about whether the device's risks outweigh its benefits!

How do you generate the necessary clinical data?
Basically there are three options:

  1. a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose, where
    • there is demonstration of equivalence of the device to which the data relates, and
    • the data adequately demonstrates compliance with the relevant essential requirements,
  2. or a critical evaluation of the results of all clinical investigations made, or
  3. or a critical evaluation of the combined clinical data provided in 1 and 2.
    For guidance see MEDDEV 2.7.1
     


 
 

Contact us

Correspondence relating to the clinical trial is to be sent to Medical Products Agency:

Department of Clinical Trials
P.O. Box 26
SE-751 03 UPPSALA
Sweden 

Please quote the Medical Products Agency reference number in all correspondence.

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information