All notification documents shall be in Swedish or English (see exceptions) and include the following parts:
Notification form
The information provided in the notification form is used by the Medical Products Agency to assess if the notification is valid and to adjust the extent of the assessment procedure.
Mandatory attachments
- Clinical Investigator´s Brochure, CIB
- Clinical Investigation Plan, CIP, with Case Report Form, CRF
- Assurance of conformity with essential requirements (see Annex 6 of LVFS 2001:5 and Annex 8 of LVFS 2003:11, respectively)
- Intended labelling of the device
- Copy of application to Ethics Review Board (and its decision and statement if available when the notification is submitted)
- Information on the patient injury insurance policy covering participating subjects
- Information to subjects (in Swedish)
- Form for subject´s informed consent to participate (in Swedish)
- Form for subject´s consent to disclosure of medical records (in Swedish)
- Affidavit of clinical investigator´s qualifications
and if applicable
- Documentation of products/medicines/agents that the device under investigation will be used together/co-operate/be compared with
- Instructions for subjects or staff
- Evaluation forms to be filled in by subjects or staff
When more than one investigation site in Sweden is participating (Swedish multi-centre investigation) a single set (original and four copies) of the notification form with attachments shall be submitted. However, the clinical investigator and the Head of department at each site shall sign the common notification form and each clinical investigator shall also sign the common clinical investigation plan.
Processing of the notification
After having controlled that the notification is complete and valid, the Medical Products Agency will acknowledge the receipt and provide the sponsor with the Agency´s reference number.
If the Agency during its examination finds reason to request additional information, such information shall reach the Agency not later than ten days after the request has been posted.
If the Agency in its assessment finds that the investigation may commence, the Agency will notify the sponsor hereof. No formal decision will be issued. If the Agency in contrast finds it necessary to disapprove the investigation, the Agency will send sponsor its formal and justified decision hereof within sixty days after the notification was filed with the Agency.
Need for essential and more extensive supplementary information or changes of the notification documents during the period of review may render it impossible to finish the process within the stipulated time period (60 days). In such cases the Agency will reject the notification in a formal Decision of Rejection and recommend the sponsor to submit a renewed notification. In this new notification the supplementary information or changes required by the Agency shall be complied with. In other parts reference may be made to previously submitted documentation.