Specific rules for medical devices
New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021.
Notification and application to the Swedish Medical Products Agency
Clinical investigations of medical devices must be notified or applied to the Swedish Medical Products Agency which coordinates the review with the Swedish Ethics Review Authority. This means that application documents that are to be examined by the Swedish Ethical Review Authority 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.
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. Application form and mandatory appendices 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.
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.
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.