New Application (VO) Form and New Format for Authorisation Applications and Changes/Notifications/Reports Regarding Clinical Trials with Medicinal Products as of 13 September 2021
According to an update posted by Swissmedic (Swiss Agency for Therapeutic Products), authorisation applications and changes/notifications/reports regarding clinical trials with medicinal products must be submitted to structure (“eDoc” structure), a new application form (“VO form”), and to a new address for submissions from 13 September 2021. Any submissions according to the old submission procedure will be deemed to be formally deficient. However, purely paperless submissions will not yet be possible as of 13 September 2021 and will be implemented at a later date. Therefore, the submissions would still be made on paper and on CD even after 13 September 2021, confirming that the files on the CD are identical with the paper documents.
For more information on the documents and instructions needed for the new procedure, please refer Clinical Trials on Medicinal Products.
Clinical Investigation of Medical Devices
According to an update posted on the Swedish Medical Products Agency (MPA), the national legislation with adaptations to EU regulation 2017/745 on medical devices (Medical Device Regulation) entered into force on 15 July 2021. The transitional requirements for clinical investigations of medical devices as per the new legislation are as follows:
- All applications and notifications for clinical investigation of medical devices in Sweden must be submitted to the MPA from 15 July 2021, until EUDAMED is fully functional. This also applies for those clinical investigations for which an ethics approval was previously sufficient
- Combined Submission Dossier: As of 15 July 2021, the ethics application is submitted by sponsor together with the application to the Swedish MPA in a combined submission dossier. The Swedish MPA will, upon receipt of an application or notification, forward relevant parts of the submission dossier to the Swedish Ethical Review Authority for assessment, so no separate submission to the Ethical Review Authority is required. With this new procedure, the sponsor is the applicant also to the Ethical Review Authority
- Clinical investigations initiated under previous legislation:
- Clinical investigations with ethics approval before 15 July 2021 may continue to be conducted in accordance with the provisions in MDR and need not submit an application or notification to the MPA retrospectively.
- For clinical investigations with ethics application submitted before 15 July 2021 but no ethical approval in place, sponsors are required to submit a copy of the ethics application and the decision letter from the Ethical Review Authority in the submission package to the Swedish MPA, after the ethical approval has been obtained.
For more details, please refer to Clinical Investigation of Medical Devices.
Clinical Trials With Medical Devices: Application and Notification (MDR)
The Swedish Medical Products Agency, regulatory agency of Sweden, has posted a bilingual guidance document on May 11, 2021, to support applicants in completion of the application or notification of a clinical investigation of a medical device under the EU regulation 2017/745 on medical devices (Medical Device Regulation).
The document has 5 sections, wherein, Section 2 relates to the Clinical Investigation Description. The different fields covered under this section are scientific opinion, design, design methodology, development stage, objectives and endpoints, synopsis, planned enrollment, duration, population details, scope, investigator contact.
For more details, please refer to Clinical Trials with Medical Devices: Clinical Investigation Application Forms.
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