| Date | Guidance No | About the guidance |
|---|---|---|
| 17 Apr 2024 | MDCG 2024-5 | Guidance on content of the Investigator’s Brochure (IB) for clinical investigations of medical devices – April 2024 When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR. The Investigator’s Brochure (IB) is part of the required documentation and is one of the means by which the sponsor is to fulfil the requirement in section 2.7 of Chapter I of Annex XV of the MDR which states that the investigator shall have access to technical and clinical data regarding the device that is being investigated This guidance document is intended to support sponsors in developing their IB by describing in greater detail what type of information is expected in the respective IB sections, in order to preempt questions from the competent authorities during the assessment of the clinical investigation application. The guidance is based on the requirements of both the MDR and ISO14155:2020 as well as experience from the competent authorities. |
| 15 Apr 2024 | MDCG 2024-4 | Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 – April 2024 This document defines SAE reporting modalities and includes a summary tabulation reporting format. |
| 15 Apr 2024 | Update – MDCG 2022-9 rev.1 | Summary of safety and performance template – April 2024 Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed). The changers to the document are stated on page 2. |
Pharmavibes
medicines-medical devices-regulatory affairs