MDCG 2024-5 Appendix A - Appendix A of the MDCG 2024-5

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MDCG 202-5 Appendix A Rev.0

Appendix A of the MDCG 2024-5

Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date.

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.

The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.

Appendix A

Cross-references between requirements in Annex XV chapter II of the MDR and the Clinical Investigation submission package

Prior to submission of the IB, sponsor may complete this checklist to ensure the IB meets the minimum requirements for validation of the application per article 70 of the MDR.

The checklist, if used, should be included together with the IB in the submission to facilitate the validation by the competent authority.

Cross-references between requirements in Chapter II Annex XV of the MDR and the Clinical Investigation submission package
Requirement		Description of requirement	Location within submission package
Annex XV Chapter II (2): Investigators Brochure (inforation in IB or enclosed as separate documents with a summary provided in the IB. If enclosed as separate documents, a clear reference within the IB should be made to the enclosed documents)	2.1	Identification and description of the device	Document Page
	2.1	Identification of the device	Document Page
	2.1	Information on the intended purpose	Document Page
	2.1	The risk classification and applicable classification rule pursuant to Annex VIII	Document Page
	2.1	Design of the device	Document Page
	2.1	Manufacturing of the device	Document Page
	2.1	Reference to previous and similar generations of the device.	Document Page
	2.2	Manufacturer’s instructions for installation, maintenance, maintaining hygiene standards and for use, including storage and handling requirements	Document Page
	2.2	Information to be placed on the label	Document Page
	2.2	Instructions for use to be provided with the device.	Document Page
	2.2	Information relating to any relevant training required.	Document Page
	2.3	Pre-clinical evaluation based on pre-clinical testing and experimental data in particular as applicable; in-design calculations, in-vitro test, ex-vivo test, animal test, mechanical test, electrical test, reliability test, sterilization validation, software verification and validation, performance test, evaluation of biocompatibility and biological safety. Summary and evaluation of pre-clinical/ non-clinical data	Document Page
	2.4	Existing clinical data, in particular available literature or other clinical data available relating to safety, performance and clinical benefit	Document Page
	2.5	Summary of the benefit risk analysis and risk management	Document Page
	2.5	Information regarding known or foreseeable risks, any undesirable side effects, contraindications and warnings	Document Page
	2.6	In case of devices that contains: medicinal substance Detailed information om the substance, and the risk management in relation to the substance, and evidence for the added value of incorporation of such constituents in relation to the clinical benefit and safety of the device	Document Page
	2.6	In case of devices that contains: human blood / plasma or derivate Detailed information om the substance, and the risk management in relation to the substance, and evidence for the added value of incorporation of such constituents in relation to the clinical benefit and safety of the device	Document Page
	2.6	In case of devices that contains non-viable tissues or cells of human or animal origin, or their derivatives Detailed information on the tissue/cell their derivate, and the risk management in relation to the tissue, cell or their derivate, and evidence for the added value of incorporation of such constituents in relation to the clinical benefit and safety of the device	Document Page
	2.7	List of fulfilment of the General Safety and Performance Requirements (GSPR). A list detailing the fulfilment of the relevant general safety and performance requirements set out in Annex I, including the standards and CS applied, in full or in part, as well as a description of the solutions for fulfilling the relevant general safety and performance requirements, in so far as those standards and CS have not or have only been partly fulfilled or are lacking.	Document Page
	2.8	A detailed description of the clinical procedures and diagnostic tests used in the course of the clinical investigation and in particular information on any deviation from normal clinical practice.	Document Page

This is the original MDCG Template that is part of the MDCG 2024-5 document Rev. 0.

Revision History

April 2024

Rev.0