May 2021: Sweden Regulatory Update

Clincal Trials With Medical Devices: Requesting CIV-ID for an Application/Notification MDR

According to an update posted on Swedish Medical Product Agency (regulatory agency of Sweden) on May 4, 2021, sponsors are encouraged to obtain a CIV-ID prior to submitting the Clinical Investigation Plan (CIP) or an application/notification for a clinical investigation to the Swedish MPA.

A CIV-ID is a unique identification number, temporary replacement for the European Single Identification Number (SIN) stated in MDR. When the European Database on Medical Devices (EUDAMED) is fully functional, a SIN will be generated when an application/notification is uploaded in EUDAMED.

The CIV-ID cannot be generated by the sponsor for an investigation and can be requested from the Swedish MPA by an e-mail with the following details in the e-mail:
• Name of the manufacturer of the medical device product
• Name of the sponsor of the investigation
• Clinical investigation title
• Protocol code (CIP-code)
• Primary objective of the investigation
• Name of the investigational medical device (trade name and/or generic name)
• Intended use of the investigational medical device

For more details, please refer to Medical Devices: Requesting CIV-ID for an application/notification MDR

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