Medical device - e-service for application/notification and modification of clinical investigation
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 investigation. More information regarding how to request a CIV-ID can be found on the Swedish MPA website:Requesting CIV-ID for an application/notification | Läkemedelsverket / Swedish Medical Products Agency (lakemedelsverket.se).Attach filesYou 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. The form may be signed manually, then please attach a separate scanned signature page.2. Clinical Investigational Plan together with a separate document describing data protection measures, if this information is not included in the Clinical Investigation Plan3. Patient information4. Insurance5. Product documentation (Investigators Brochure, Declaration of conformity etc)6. Investigators and investigational sites7. Other documentsIf there are several documents in a category, name them 3a+Document name, 3b + Document name etc and/or make a folder.If a substantial modification submission includes plenty of documents, the same folder structure as above may be used. Otherwise, separate documents can be attached.Files can be attached in the following formats: pdf, doc, docx, xls, xlsx, tif, gif, txt, zip and jpeg.All files must be fully searchable.For further instructions regarding attachments to be included in the application/notification, please see the Swedish MPA website for clinical investigations of medical devices:Application and notification | Läkemedelsverket / Swedish Medical Products Agency (lakemedelsverket.se)There you can also find the document “Guidance on Clinical investigation application form”. Check that the e-mail address filled in below (the one you will state as sender) and selected attachments are correct before submitting. Then submit the application form and attachments by clicking the "Submit" button.
JavaScript är inte aktiverat i din webbläsare! För att e-tjänsten ska fungera korrekt behöver du aktivera JavaScript.
Information om hur du aktiverar JavaScript kan du få genom att söka i hjälpfunktionen i din webbläsare eller söka på webben.
Thank you!
E-mail address
Attach file
Information about how the Swedish Medical Products Agency processes personal dataPersonal data provided when an application or notification of a clinical investigation 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. 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 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 MPA is responsible for the personal data processing. If you want to know if the 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 MPAs 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), P.O. Box 26, 751 03 Uppsala, SwedenFront desk: + 46 18 174600E-mail: registrator@lakemedelsverket.se