Requesting CIV-ID for an application/notification – MDR
- Published: May 4, 2021
- Last updated: October 18, 2024
A CIV-ID is a unique identification number for each clinical investigation which cannot be generated by the sponsor. A CIV-ID can be provided by the competent authorities. It is sufficient to contact only one authority to receive a CIV-ID, even if the investigation will be performed in several countries.
The CIV-ID is a temporary replacement for the European Single Identification Number (SIN) stated in MDR (see article 70.1) and should be used in all relevant communication regarding the clinical investigation.
When EUDAMED is fully functional, a SIN will be generated when an application/notification is uploaded in EUDAMED. According to section 3.1 in chapter II, annex XV MDR the identification number should be stated in the Clinical Investigation Plan (CIP).
Sponsors are therefore encouraged to obtain a CIV-ID prior to submitting the CIP 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 e-mail to request a CIV-ID for your investigation, unless a CIV-ID has already been obtained from another competent authority.
Submitting your request:
- State the following in the e-mail subject header: ”CIV-ID request for application/notification of a clinical investigation”
- 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:
- Manufacturer of the medical device product (name and contact details)
- Sponsor of the investigation (name and contact details)
- Clinical investigation title
- Protocol code (CIP-code)
The "CIP code" is Sponsor’s unique code for the specific clinical investigation and should be specified on the clinical investigation plan (CIP). It usually consists of a sequence of letters and/or numbers and is created by the Sponsor. - Primary objective of the investigation
- Name of the investigational medical device (trade name and/or generic name)
- Intended use of the investigational medical device
- 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.
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