Specific rules for medical devices
New rules apply from 26 May 2021 - but some are delayed (preliminary) until 15 July 2021. Updates regarding the rules from 15 July will be published early autumn.
Notification to the Swedish Medical Products Agency
Some clinical investigations of medical devices must be notified or applied to the Swedish Medical Products Agency. Find out more under the page Planning on this website.
What must be submitted to the Swedish Medical Products Agency and the Swedish Ethical Review Authority?
Different levels of authorization procedures are applied, but regardless of which procedure is applied, the requirements for the documentation that must be submitted to the Swedish Medical Products Agency are the same.
Registration form and detailed instructions for registration are available on the Swedish Medical Products Agency's website. Registration form and mandatory attachments are submitted electronically. The appendices to the application are defined in the application form. In some cases it is recommended that they 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.
One of the appendices- "Declaration of conformity" - must be issued by the manufacturer. Note that this document is a different declaration of conformity than the one made by the manufacturer regarding the CE marking. You can find a template on the Swedish Medical Products Agency's website. The appendix is a confirmation that the product in question complies with the general requirements, apart from the aspects that constitute the purpose of the examinations and that, taking into account these aspects, all precautions have been taken to protect the health and safety of the patient, users and others. All medical technical clinical trials also require a separate application to the Swedish Ethical Review Authority. Certain application documents, such as the clinical trial plan, must be sent to both the Swedish Ethical Review Authority and the Swedish Medical Products Agency. For these documents, it should be ensured that the authorities have the same version of the documents on which to base their decisions.
What happens to my application?
The scope of the Swedish Medical Products Agency's review and how long it takes to receive a response to your application depends on which permit procedure is applied.
In case the trial is to 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.