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Specific rules for medical devices

Medical devices are in the EU regulated by two categories that follow different regulations:

  • For medical devices, the EU Regulation on Medical Devices (MDR) applies. New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021.
  • For in vitro diagnostic medical devices, the EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) applies. New rules apply within the EU from 26 May 2022.

Medical devices, EU regulation MDR


Notification and application to the Swedish Medical Products Agency
Most of the clinical investigations of medical devices must be notified or applied to the Swedish Medical Products Agency. In most cases the Swedish Medical Products Agengy coordinates the review with the Swedish Ethics Review Authority. This means that it it the sponsor who submits the application documents that are to be examined by the Swedish Ethical Review Authority when they are attached to the notification or application that is sent to the Swedish Medical Products Agency. Find out more under the page Planning on this website. External link.

It is only clinical investigations of CE-marked medical devices, where the study participants are not exposed to further invasive or strenuous procedures that are not coordinated as above. That is, here it is still the principal investigator who applies for the ethical review directly to the Ethics Review Authority via the application portal Ethix.

What must be submitted to the Swedish Medical Products Agency and the Swedish Ethical Review Authority?
Whether it is an application or notification the requirements for the documentation to be submitted for review are the same. The dossier excits of an application form and mandatory appendices which are submitted electronically. The mandatory appendices to the application form are defined in each authority's application form (see links below).

Appendices such as trial handbook, written information to be provided to study participants and the clinical trial plan is recommended to be designed in accordance with ISO 14155: 2020, read more under the section Planning. The appendices must, among other things, show that the test product is ready for a medical technical clinical trial, ie that the product meets the general requirements for safety and performance apart from the aspects covered by the study.

General requirements for security and performance

What happens to my notification or application?
Depending on which permit procedure is applied, the authorities' review will be differently extensive and run according to different deadlines. The most comprehensive review procedure takes 45 days after a valid application is received.

For medical technical clinical trials that have been reported to the Swedish Medical Products Agency, the Swedish Ethical Review Authority makes a decision within 30 days (no further decision is received from the Swedish Medical Products Agency).

For medical technical clinical trials applied for to the Medical Products Agency, and the product is:

  • invasive in class IIa or IIb or a product in class III, the Swedish Medical Products Agency and the Swedish Ethical Review Authority make a coordinated decision within 45 days
  • class I or non-invasive product in class IIa or IIb, a validation notice from the Swedish Medical Products Agency must be awaited and thereafter the Swedish Ethical Review Authority makes a decision within 40 days.

Information about the authority's review and permit procedures, the Swedish Medical Products Agency's website External link.

Information about the authority's review and permit procedures, the Swedish Ethical Review Authority's website External link.

If the trial will take place in several countries, there will be possibile to have a coordinated permit procedure within the EU. The coordinated procedure is being implemented in the EU. To investigate the possibility of a coordinated procedure, contact the Swedish Medical Products Agency.

Investigate the possibility of a coordinated licensing procedure, the Medical Products Agency's website External link.

Includes your clinical investigation of medical device biobank test
If your clinical trial includes a biobank test, an approved biobank application is required.

The Regional Biobank Center is also part of the coordinated process to facilitate the establishment of the biobank agreement. A Biobank application must always be submitted to the Regional Biobank Center at the same time as the application for clinical trials is sent to the Medical Products Agency.

Application routine for medical devices, Biobank Sweden's website (in Swedish) External link.

Medical devices for in vitro diagnostics, EU regulation IVDR


Registration and application to the Swedish Medical Products Agency
The new IVD legislation introduces requirements for applications for a permit and a notification obligation to the Swedish Medical Products Agency for certain types of clinical performance studies of in vitro diagnostic products. Read more under the section Planning.

Clinical performance studies that are subject to notification to the Swedish Medical Products Agency are such studies that involve:

  • treatment-indicating diagnostics performed using residual sample material
  • that a CE-marked diagnostic product is studied within the framework of the intended purpose, but the study involves further invasive or strenuous procedures for the subject.

Clinical performance studies that are subject to application to the Swedish Medical Products Agency are such studies that involve:

  • an interventional study of clinical performance
  • that surgically invasive sampling is performed and where the procedure is performed solely for the purposes of the study
  • that further invasive procedures or other risks for the subjects are performed, even if these have nothing to do with the sampling procedure
  • treatment-indicating diagnostics where samples / materials are taken specifically for the study.

These types of performance studies must be reported or applied to the Swedish Medical Products Agency, which coordinates the review with the Swedish Ethical Review Authority. This means that application documents that are to be examined by the Swedish Ethics Review Authority are attached to the notification or application that is sent to the Swedish Medical Products Agency.

However, many performance studies will continue to be able to be carried out without either notification or application to the Swedish Medical Products Agency. These must then apply for ethical review to the Swedish Ethical Review Authority via the Ethix application portal.

What should be sent to the Swedish Medical Products Agency and the Swedish Ethical Review Authority, respectively?
Regardless of whether it is an application or notification, the requirements for the documentation to be submitted for review are the same and are set out in Chapter I of Annex XIV of IVDR. Application form and mandatory appendices are submitted electronically.

Instructions for registration and application, the Swedish Medical Products Agency's website External link.

Application form and instructions for application, the Swedish Ethical Review Authority website (in Swedish) External link.

Appendices such as trial handbook, written information to be provided to study participants and the clinical performance study plan is recommended to be designed in accordance with ISO 20916: 2019, read more under the section Planning. The appendices must, among other things, show that the trial product is ready for a medical technical clinical trial, ie that the product meets the general requirements for safety and performance apart from the aspects covered by the study.

General requirements for safety and performance

What happens to my registration or application?
Depending on which permit procedure is applied, the authorities' review will be different in scope and run according to different deadlines. The most comprehensive review procedure takes 45 days after a valid application is received.

For clinical performance studies reported to the Swedish Medical Products Agency, the Swedish Ethical Review Authority makes a decision within 30 days (no further decision is received from the Swedish Medical Products Agency).

For clinical performance studies applied to the Swedish Medical Products Agency, the Swedish Medical Products Agency and the Swedish Ethical Review Authority make a coordinated decision within 45 days.

Information about the Swedish Medical Products Agency's review and permit procedures External link.

Information on the Swedish Ethics Review Authority's review and permit procedures (in Swedish) External link.

Includes your medical technology clinical trial biobank test
If your clinical trial includes a biobank test, an approved biobank application is required. The Regional Biobank Center is also part of the coordinated process to facilitate the establishment of the biobank agreement. A Biobank application must always be submitted to the Regional Biobank Center at the same time as the application for clinical trials is sent to the Swedish Medical Products Agency.

Application routine for medical devices, Biobank Sweden's website (in Swedish) External link.