Investigational Medical Device Dossier <product>, version <XX.YY>.
<Date>
TABLE OF CONTENTS
Abbreviations 3 Scope 4 IMDD format 4 Information to be submitted 4 1.Device description and specification, including variants and accessories 6
1.1Device description and specification 6
1.2Reference to previous and similar generations of the device 7
2.Information to be supplied by the manufacturer 7
3.Design and manufacturing information 8
4.General safety and performance requirements 9
5.Benefit-risk analysis and risk management 9
6.Product verification and validation 10
6.1Pre-clinical and clinical data 10
validation verification
6.2Additional information required in specific cases 12 References 14 Appendix I Table of contents for the IMDD to be submitted 15 Appendix II Checklist GSPRs 16 Appendix III Risk management 18
Abbreviations
CE  Conformité Européenne
CMR  Carcinogenic, mutagenic of toxic to reproduction
EN European standard
GSPR General Safety and Performance Requirement
IMDD Investigational Medical Device Dossier
ISO International standard or the International Organization for Standardization MDR Medical Devices Regulation 2017/745
MREC Medical Research Ethics Committee
NEN Dutch standard
PMCF Post-market clinical follow-up
QMS Quality Management System
SSCP Summary of Safety and Clinical Performance
STED Summary TEchnical Documentation
Scope
The Investigational Medical Device Dossier (IMDD) specifies all items that must be covered (if relevant) for an application to a Medical Research Ethics Committee (MREC) in the Netherlands. This document is written for non-CE-marked medical devices within the scope of the Medical Devices Regulation 2017/745 (MDR) [1], which are intended for clinical investigation. If a non-CE-marked medical device, manufactured and used only within a single health institution (in-house manufactured medical device), is subject to a clinical investigation, all items specified in this IMDD are also considered applicable. A clear rationale and justification shall be provided for any deviation(s) from the IMDD. For CE-marked medical devices used outside the intended use, the format of the IMDD can also be used, see also the paragraph on information to be submitted.
Good clinical practice and the design and conduct of the clinical investigation are outside the scope of the IMDD and shall be described in the clinical investigation plan. The requirements regarding personal data protection are also outside the scope of the IMDD.
IMDD format
The requirements for information to be submitted by a sponsor of a clinical investigation with a non CE-marked medical device are laid down in Annex XV of the MDR. However, the information to be sub
mitted is mostly stated generally. Section 4.6 of Chapter II of Annex XV allows the competent authority to request additional information to be submitted. Annex II of the MDR contains detailed requirements for the technical documentation that a manufacturer has to compile to prove that the medical devices meet the requirements of the MDR. To facilitate uniform submission of documentation for medical devices for clinical investigation, it was decided to use the technical documentation requirements as specified in Annex II of the MDR as the basis for the documentation to be submitted. This IMDD guidance document provides additional guidance on the interpretation of some parts and provides information on the required documentation to be submitted, see paragraphs 1-6.  The first version of the IMDD was published in 2011 and was based on the Summary TEchnical Documentation (STED) drawn up by the Global Harmonization Task Force [2]. The required information in this updated version of the IMDD does not significantly differ from the information required in the first version of the IMDD. However, the structure and numbering of the items to be submitted are different.
The text of Annex II of the MDR is presented in normal type font. Reference to annexes in that part of the IMDD refer to Annexes of the MDR. For the IMDD, reference is made to appendices. Bold text is guidance to the required information in the MDR.
Where it is mentioned in Annex II of the MDR that a medical device is ‘placed on the market’, for the I
MDD, this should be read and understood as ‘used in the clinical investigation’. The term ‘manufacturer’ could in several instances be read and understood as ‘sponsor of the clinical investigation’.
Information to be submitted
The sponsor of the clinical investigation, regardless whether it is a legal manufacturer or an investigator, shall use the IMDD format for submitting the required documentation to the MREC. The information in the IMDD and the information referred to in the IMDD can be submitted in English or in Dutch.
To obtain adequate and complete information in the IMDD, active involvement of the manufacturer of the investigational medical device is advisable, as they should have all technical information required for the IMDD available.
The information requested in the IMDD shall be compiled in a documentation set. The documentation set shall be presented in a clear, organised, readily searchable and unambiguous manner.
If an IMDD item is dealt with in another item or document supplied for the clinical investigation, for inst
ance the investigator’s brochure, as described in NEN-EN-ISO 14155 [3], or technical construction file, reference to that item or document is acceptable when a brief description of the information in that item or document is provided in the IMDD. Appendix I of the IMDD provides a table of contents for the documentation set. Using that
table, cross references can be made between the items required by the IMDD and the documents submitted. If an item of the IMDD is not applicable for a medical device (e.g.
‘electrical safety’ or ‘medicinal substances’), this shall be clearly indicated.
If separate documents are submitted, each document shall include a date/version number and identify author(s) that contributed significantly.
If the information to be submitted for one or more items (e.g. software validation for imaging devices) is very extensive, the level of detail of the documentation for such items shall be agreed upon with the MREC.
In case the sponsor intends to change (the intended purpose of) an already CE-marked medical device and needs clinical investigation data to support the change, no full IMDD of the original medical
device needs to be submitted. The documentation submitted shall contain a clear description of the change(s) as compared to the CE-marked medical device and its intended use(s) and a rationale for the change to the medical device. The documentation shall contain a description which items of the IMDD are affected by the change and updated documentation on these items shall be submitted. The items medical device description (item 1), instructions for use (item 2), risk benefit analysis (see item 5) and General Safety and Performance Requirements (GSPRs, see item 4) will always have
to be submitted. This will provide insight into the changes and how all GSPRs are addressed for the new design/intended use and how additional risk related to the change have been addressed.
If a Summary of Safety and Clinical Performance (SSCP) has been drawn up for a CE-marked medical device as described above, this SSCP shall also be supplied.
In the IMDD, the use of harmonized standards for fulfilling requirements of the MDR is preferred. Therefore, harmonized standards are referred to when applicable. Other solutions can be used, but a rationale shall be provided why this is considered similar to
the approach in the harmonised standard.
Certain aspects, such as interoperability or usability, that are considered crucial by the MREC or investigators, might not be elaborated upon in the requirements in the MDR and therefore in the IMDD. Additional requirements can be discussed between the investigators, sponsor and MREC, as applicable.
1.Device description and specification, including variants and
accessories
1.1 Device description and specification

版权声明：本站内容均来自互联网，仅供演示用，请勿用于商业和其他非法用途。如果侵犯了您的权益请与我们联系QQ:729038198，我们将在24小时内删除。