According to Annex I.B.7 (i) of the CTR, the clinical trial sponsor shall include in the Cover letter the list of medical devices which are to be investigated in the clinical trial but which are not part of the investigational medicinal product or products, together with a statement as to whether the medical devices are CE-marked for the intended purpose. This should be understood to refer to medical devices (including IVDs) which are specifically required by the protocol to be used to achieve the objectives of the trial.
Use of an IVD in a clinical trial may meet the definition of a device for performance study. (See glossary ‘device for performance study’ and ‘performance study’)
For each device used in the clinical trial that meets the definition of a device for performance study, the sponsor of the clinical trial should comment on the need for notification or application for the clinical performance study conducted in parallel with the clinical trial, based on the applicable IVD legislation. Reference should be made to EUDAMED Single Identification Number (SIN) and/or National Competent Authority reference numbers (if available) for planned or submitted performance studies. To facilitate bridging between clinical trial and performance study, the IVD being used should be identified in the cover letter and protocol of the clinical trial.
Where the IVD manufacturer is supporting the clinical trial, which is also a performance study, the clinical trial sponsor should obtain a statement from the IVD manufacturer that the device for performance study in question conforms to the general safety and performance requirements laid down in Annex I of the IVDR, apart from the aspects covered by the clinical performance study and that, with regards to those aspects, every precaution has been taken to protect the health and safety of the subject.
Where the clinical trial sponsor is also the manufacturer of the IVD or assumes the role as manufacturer of the IVD according to Article 16 IVDR, the clinical trial sponsor must draw up their own statement as above. In case the study falls under IVDR Art 58 (1) or (2), it must be designed, authorised, conducted, recorded and reported in accordance with IVDR Art. 58-77 and Annex XIV.
In the CTA cover letter, the availability of this statement should be confirmed, and the aspects that are covered in performance study as part of the clinical trial should be listed. The statement is to be kept with the sponsor’s trial master file (TMF) and investigators’ site file (ISF) and made available for inspections or at the request of NCAs.
In case of confidential information in the description of the performance studies, a redacted cover letter can be submitted, as necessary.
In addition, further details on compliance with IVDR and Annex I of the IVDR can be provided in the protocol, according to CTR Annex I 17. a)-f).