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

CIV-ID temporarily replaces the European identification number (Single Identification Number, SIN) stated in the IVDR (see Article 66) and should be used in all relevant communication regarding the performance study.
When EUDAMED is fully functional, a SIN will be generated when an application/notification is uploaded in EUDAMED. According to sections 2.3.2 and 3, part A in Annex XIII of the IVDR, the identification number should be stated in the clinical performance study plan (CPSP).

Sponsors are therefore encouraged to obtain a CIV-ID prior to submitting the CPSP to the Swedish MPA. However, it is possible for the authority to generate a CIV-ID when the first application/notification is received if this has not already been done.

How do I request a CIV-ID as a sponsor?

Before an application/notification is submitted, please contact the Swedish MPA by email to request a CIV-ID for your performance study, unless a CIV-ID has already been obtained from another competent authority.

Submitting your request:

• State the following in the email subject header:
  ”CIV-ID request for application/notification of a performance study”
• In order for the Swedish MPA to be able to generate a CIV-ID, certain information is needed.

Please provide the following details in your email:

1. Manufacturer of the in vitro diagnostic medical device (IVD) (name and contact details)
2. Sponsor of the study (name and contact details)
3. Study title
4. Protocol code/CPSP code
5. Primary objective of the study
6. Name of the IVD (trade name and/or generic name)
7. Intended use of the IVD

Please email your request to: registrator@lakemedelsverket.se

The Swedish MPA will communicate the CIV-ID by answering the email request within a few working days.