This guidance is intended to support sponsors in developing the Investigator’s Brochure (IB). It outlines the requirements for sponsors submitting applications for clinical investigations under the MDR and emphasizes the importance of providing complete documentation, including the IB, which must contain technical and clinical data on the device being investigated. The IB should adhere to the content requirements outlined in Chapter II of Annex XV of the MDR. Sponsors are encouraged to refer to both the MDR and ISO14155:2020 when preparing the IB to ensure compliance and thoroughness. Updates to the IB must be promptly communicated to investigators and relevant authorities, with changes clearly identified.
For further details, please consult the reference provided.