Application for performance studies
According to IVDR Article 66, to apply for a performance study, the sponsor must submit an application to the Member State(s) in which the study is to be conducted, accompanied by the following documentation:
- Application form
- Investigator’s brochure
- Performance study plan
- A signed statement by the manufacturer indicating that the device conforms to the general safety and performance requirements apart from the aspects covered by the study
- A copy of the opinion of the ethics committee
- Proof of insurance or indemnification in case of injury
- Documents used to obtain informed consent
- Description of the arrangements on data protection and confidentiality
- Available technical documentation
The IVDR states that the application must be submitted through EUDAMED. However, in the absence of the platform, a series of performance study application documents have been created.
On December 2022, it was published the MDCG 2022-19 related to the performance study application documents under the IVDR.
These documents are annexed to the MDCG document and include:
- Performance study – application form under the IVDR
- Addendum to the performance study application form for:
- Additional device(s)
- Additional comparator
- Additional site(s)
- Performance study support documents – Documents to attach
- Checklist of general safety and performance requirements, standards, common specifications and scientific opinions
These templates will be withdrawn once the EUDAMED module for performance studies is fully functional.
Performance study identification numbers
In the absence of EUDAMED, the Union-wide unique single identification number for a performance study, will be the CIV-ID which can be generated in EUDAMED2, the platform developed to support the old Directives.