Medical device/IVD-product - e-service for application/notification/modification of clinical investigation/performance study

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This e-service can be used to upload and submit application forms and attachments.

Before you submit an application/notification, please contact the Swedish MPA to request a CIV-ID for your clinical investigation/performance study.

More information regarding how to request a CIV-ID can be found on the Swedish MPA website:

Requesting CIV-ID for an application/notification - according to MDR.

Requesting CIV-ID for an application/notification - according to IVDR.

There you can also find the guidance document “Guidance on Clinical investigation application form”, describing how to fill out the application/notification form.

Attach files

You can either upload the entire application/notification as a zip file or as separate documents. When you submit an initial application/notification or a resubmission, please upload the attachments according to the following structure:

  1. Application form – electronically completed with date and signature. If the form is signed manually, please attach a separate scanned signature page.
  2. Clinical investigational Plan/Performance study plan together with a separate document describing data protection measures, if not included in the Plan
  3. Patient information
  4. Insurance
  5. Product documentation (Investigator's Brochure, Declaration of conformity etcetera)
  6. Investigators and investigational sites
  7. Other documents

If there are several documents in the same category, name them e.g. 3a + Document name, 3b + Document name and/or make a folder.

For substantial modifications only amended documents need to be submitted. Please upload one clean version and one version with tracked changes for each of the amended documents.

If a substantial modification submission includes many documents, preferably use the same folder structure as above. Otherwise, separate documents can be attached.

Files can be attached in the following formats: pdf, docx, xlsx, tif, gif, txt, zip and jpeg. All files must be fully searchable.

Check that the email address filled in below (the one you will state as sender) and selected attachments are correct before submitting the application form and attachments by clicking the "Submit" button.

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Thank you!

Attach file
Typ av dokument
Tillåtna filändelser
Tillåtet antal
 
Attached documents
pdf, docx, xlsx, tif, gif, txt, zip, jpeg
minst: 1
maximalt: 20
Information about how the Swedish Medical Products Agency processes personal data Personal data provided when an application or notification of a clinical investigation/performance study is submitted via the e-service will be processed by the Swedish Medical Products Agency (MPA). The personal data includes name, address, telephone number and e-mail address concerning sponsor staff and other participating study staff in the clinical investigation/performance study. The purpose of the data processing is to process applications or notifications of clinical investigations and clinical performance studies, the agency is also responsible for their supervision. Provision of the personal data is a requirement under Chapter II, Annex XV of EU Regulation 2017/745 (MDR) and Chapter I, Annex XIV of the EU Regulation 2017/746 (IVDR) respectively. Because the application or notification of a clinical investigation or performance study is to be assessed by the Swedish MPA and the agency is also obliged to supervise clinical investigations and performance studies, the legal basis for the processing is that it is necessary in the exercise of official authority. The personal data will be stored in accordance with the Archives Act. The Swedish Ethical Review Authority will be given access to the provided personal data. The Swedish MPA is responsible for the personal data processing. If you want to know if the Swedish MPA processes personal data about you, you can contact the authority. If you want your personal data rectified, if you want to request a restriction of the processing or have your personal data erased, you can also contact the authority. In some cases, you also have the right to object to the processing of your personal data. If you have a complaint about the Swedish MPA's processing of your personal data, you can contact the authority and/or the Swedish Authority for Privacy Protection. How to contact us and the data protection officer: Postal address: Swedish Medical Products Agency (Läkemedelsverket)
Box 26
751 03 Uppsala
Sweden Switchboard: + 46 (8) 174600 Email: registrator@lakemedelsverket.se