Technical

Documentation
According to the Medical Device
Regulation (EU) 2017/745 (MDR)

TÜV SÜD
1
Contents Introduction
INTRODUCTION 3 Manufacturers of medical devices seeking to place their products on the EU Single Market or put medical devices
into service that are not placed on the market need to have the conformity of their products assessed according to
CONFORMITY ASSESSMENT PROCEDURES UNDER THE MDR 4 the applicable conformity assessment procedures set forth in the Medical Device Regulation (EU) 2017/745 (MDR)
Annexes IX to XI [Art. 52 (1) (2)].
SUBMISSION OF TECHNICAL DOCUMENTATION 5
Depending on the conformity assessment procedure selected, manufacturers may also have to involve a notified
body. However, in any case they need to draw up Technical Documentation for their medical devices and keep it
CONTENT REQUIREMENTS – TECHNICAL DOCUMENTATION GUIDANCE ANNEX II 6
up to date. This Technical Documentation shall allow assessment of the conformity of the device with the relevant
requirements of the MDR [Art. 10 (4)].

This document aims to familiarise stakeholders with the requirements set forth in Annex II to the Medical Device
Regulation. It provides information on the elements that need to be included in the Technical Documentation and how
said Technical Documentation can be provided to TÜV SÜD.

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Conformity Assessment Procedures under MDR Submission of Technical Documentation
Class I The data included in the Technical Documentation is preferably taken from the manufacturer’s systems. The
To demonstrate the conformity of class I devices, manufacturers draw up the Technical Documentation according Technical Documentation retrieves information from one or several databases and presents it in human-readable
to Annexes II and III and issue an EU Declaration of Conformity (DoC). For devices that are placed on the market form.
in a sterile condition, have a measuring function or are reusable surgical instruments, manufacturers shall apply
the conformity assessment procedure based on a quality management system and on assessment of Technical At most medical device manufacturers, the data used in the Technical Documentation are spread over different
Documentation explained in Chapters I and II of Annex IX, or conformity assessment based on product conformity sources and IT systems. Given this, TÜV SÜD will continue to accept Technical Documentation in PDF format with a
verification according to Part A of Annex XI. In case of class I devices, the role of notified bodies is limited to certain systematic file structure.
aspects [Art. 52 (7)]. Accepted formats are:
§ PDF, searchable, Optical Character Recognition (OCR) applied
Class IIa § Microsoft Office documents
Class IIa devices are subject to conformity assessment based on a quality management system as specified in Annex § In future as XML using a format or an interface provided by TÜV SÜD
IX, Chapters I and II and an assessment of Technical Documentation (Annex IX, Chapter II, Section 4) of at least
one representative device for each category of devices [Art. 52 (6)]. Alternatively, manufacturers can draw up the Accepted formats for graphical information:
Technical Documentation according to Annexes II and III and opt for a conformity assessment based on production § JPG, PNG, BMP, GIF or any other common graphic file format that can be viewed without specific software
quality assurance and product verification as specified in Sections 10 and 18 of Annex XI. The assessment of the § Constructional and design drawings can be also provided as files
Technical Documentation shall apply for at least one representative device for each category of devices [Art. 52 (7)]. § Videos – any common file format that can be viewed without specific software

Class IIb For the structure of the Technical Documentation, see Annex II, which provides useful guidance. Bookmarks, links,
Class IIb devices are subject to conformity assessment based on a quality management system as specified in glossaries and indexes help to navigate the Technical Documentation.
Annex IX, Chapters I and III and an assessment of the Technical Documentation (Annex IX, Chapter II, Section 4)
of at least one representative device per generic device group. For class IIb implantable devices, except sutures, To merge several PDF files into one very large PDF or PDF portfolio shall be avoided. Complex folder structures in
staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the submissions may make it more difficult to search for evidence or understand the Technical Documentation. Long file
assessment of the Technical Documentation according to Annex IX, Chapter II (4) shall apply for every device [Art. 52 names might affect compatibility to the IT infrastructure and must therefore be avoided.
(4)].
How to submit your Technical Documentation to TÜV SÜD
Class III and Class IIb defined in Article 52 (4)
Class III devices and class IIb devices as defined in Article 52 (4) shall be subject to a conformity assessment
Provision of access to your Technical Documentation is critical for
exchanging information. As a manufacturer, you aim to make sure that your
As a manufacturer,
according to Annex IX based on a quality management system and on assessment of the Technical Documentation data is protected and cannot be accessed by unauthorised parties. Given you aim to make
relating to the device which the manufacturer plans to place on the market or put into service and which is this, a password-protected and controlled environment for file submission sure that your data
covered by the quality management system. Alternatively, the manufacturer may choose to apply for a conformity is key. Files provided through a non-password-protected static link are is protected and
unacceptable in terms of data security.
assessment based on type examination as specified in Annex X coupled with a conformity assessment based on
product conformity verification as specified in Annex XI [Art. 52 (3)].
cannot be accessed
If you wish to share huge files, either use your company’s in-house solution by unauthorised
or ask your TÜV SÜD representative for the best way of submitting parties.
your Technical Documentation to TÜV SÜD. Do not send a Technical
Documentation via email as this is not a suitable way to transfer huge file
packages.

There are various tools that support the e-submission process and further tools are under development. Ideally,
all files should be packed into a single, or a small number of, downloadable ZIP archive(s). Please use a file sharing
platform that allows collective download of these files. Do not submit vast numbers of documents as separate
downloadable files.

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Content Requirements – for assessment and will check the compliance to language requirements during audit activities. For support this
Technical Documentation Guidance Annex II approache TÜV SÜD will request to receive the applicable procedure for translation of such information, therefore,
please include it from the beginning in your Technical Documentation. In case several variants of a medical device
exist it will not be sufficient to provide one exemplary set of information but the complete set of information for all
variants in German or English.
According to the introduction to Annex II to the MDR, Technical Documentation shall include the elements listed
in Annexes II and III to the MDR. Annex II basically provides a checklist of mostly well-established elements to be
included in the Technical Documentation.
SECTION Design
03 and manufacturing information
Annex II comprises 6 sections which will be described in more detail below.
This section includes one of the most significant changes compared to MDD/

SECTION Device description and specification, AIMDD requirements on Technical Documentation and Design Dossiers.
As a conformity
01 including variants and accessories Manufacturers must submit information to allow the Design Stages applied assessment
to the device to be understood. In other words, they must furnish evidence procedure for a
Each Technical Documentation shall begin with a section providing a device description, device specifications, a list that the device went through design stages and explain changes between medical device is
individual design stages of the device (if any) in a manner comprehensible to
of variants, combinations and model numbers/names as well as a list of accessories which are intended to be used
the reader (reviewer).
mainly a combination
with the device. Accessories shall not only be limited to those delivered with the device (e.g. in the same sterile
package) but shall also cover those accessories generally used with the device to support its intended purpose. The
of auditing,
device-related Basis UDI-DI shall be provided for each variant as well as device related nomenclature such as MD To fulfil this requirement, manufacturers need to submit device-related testing and review
coding as per implementing regulation 2017/2185, EMDN (CND) code to additionally support TÜV SÜD assessment of evidence (submission of a Design and Development SOP is not enough). Such
information is typically found in a Design History File of a device.
activities, the
Technical Documentation.
overall conformity
Further information to be provided in this section include explanations of novel features, i.e. features that are new When manufacturers request a conformity assessment procedure under assessment
in a device compared to the predecessor device or similar devices on the market. Where necessary, reference can the MDR for a device that was placed on the market under the AIMDD/MDD procedure must
and was thus developed prior to the MDR, the information they submit must
be made to attachments to the Technical Documentation (e.g. the justification for classification of the device when
include any design iterations performed after the product had been made
cover all relevant
prepared as a checklist based on Annex VIII).
available on the market initially. elements.
Please note that section 1 of the Technical Documentation is important for the basic understanding of the device and
should therefore be clear and easily readable. The Technical Documentation of such a device must reflect the current
design stage, including all changes made in the past. The information submitted must be such that the reader can
Provision of all information in the form of attachments might not make for easy reading and understanding. A understand the reasons for any changes effected in the post-marketing phase.
document that guides the reader (reviewer) through the required elements of the Technical Documentation will be
easier to read and avoid misunderstandings. Under letter (b), this section requires information and specifications, including the manufacturing processes and their
validation, their adjuvants, the continuous monitoring and the final product testing. All elements listed under (b) and
the data associated shall be fully included in the Technical Documentation.
SECTION Information to be supplied
02 by the manufacturer
As a conformity assessment procedure for a medical device is a combination of auditing, testing and review
activities, the overall conformity assessment procedure must cover all relevant elements. While the Technical
Documentation shall also include process-related data, these data are ideally assessed in the on-site audit at the
Section 2 covers all information that manufacturers need to provide along with the medical device under manufacturer. In order to assess a reasonable set of information in this section, TÜV SÜD requests the following
assessment. This firstly includes labels and instructions given to users and/or patients but also information device specific information to be included in the Technical Documentation:
provided by other means as well as the implant card where applicable. Labels and instructions must be provided ƒ Manufacturing procedure including a flow chart and information about used adjuvants
in the languages accepted by the Member States where the device is envisaged to be sold. This might prove a ƒ Quality control measures (i.e. continuous monitoring and final product testing)
challenge, in particular when translations of such information are still pending. However, the MDR does not include ƒ Manufacturing master validation plan and the associated summary report referencing individual IQ/OQ/PQ plans
any requirement that medical devices must be placed on the entire EU market right from the start. Manufacturers and reports
can thus choose the markets where the device is envisaged to be sold and adjust the languages of the Technical ƒ IQ/OQ/PQ plans and reports for non-critical/crucial processes shall be on file at the manufacturer or EU
Documentation accordingly. TÜV SÜD will accept information in this section in the languages German or English representative and shall be provided to TÜV SÜD upon request

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ƒ IQ/OQ/PQ plan and reports for critical/crucial processes (e.g. sterilisation, packaging, and others) shall be As the Technical Documentation must be clear and unambiguous, a general reference to a specific folder that
provided initially with the Technical Documentation to TÜV SÜD includes a large number of documents is not acceptable. Instead, a clear identifier, pointer or link to the evidence
shall be provided.
In case clarification is needed if a process validation shall be included in the Technical Documentation initially or can
be kept available and be provided upon request get in touch with your TÜV SÜD client manager. GSPR-related information is extremely complex. Databases and requirements tracking tools combined with unique
information units are emerging as one possible solution for appropriately handling these huge amounts of data.
Section 3 also requires identification of all sites that perform design and manufacturing activities, including sites of
suppliers and subcontractors. The requirement very clearly specifies “all” sites, (...) suppliers and subcontractors.
SECTION Benefit-Risk Analysis
05
In addition, the Technical Documentation must provide manufacturing information on aspects such as processes
and their validation, a list of suppliers and subcontractors (...) that carry out design and manufacturing activities and Risk Management
either individually or in combination with each other. Manufacturers also might have to check and update supplier
agreements to make sure they contain all information that is relevant for the conformity of a medical device. As As risk management has always been the backbone of development, manufacturing, and conformity assessment of
manufacturers have sole legal responsibility for their medical devices, they must have access to all conformity- medical devices, Section 5 of Annex II does not include new requirements compared to the past.
related information, including that of suppliers and subcontractors. Information about manufacturing and design
activities at suppliers and subcontractors is part of the conformity assessment and might be assessed by General information on benefit-risk analysis, solutions adopted and the results of risk management shall be provided
TÜV SÜD. Such information must be provided by the manufacture directly and cannot be accepted from the supplier according to this section.
or subcontractor directly, bypassing the manufacturer.
Solutions adopted can include a variety of possibilities, from design-related solutions to protective measures, warnings,
A limitation to suppliers which have direct relations to the manufacturer, might be acceptable in some cases. instructions, functional-safety elements, training and other measures.
However, in other cases such limitation might not be acceptable (e.g. for materials of animal or human origin or other
critical materials or components). Stricter requirements related to the management of risks, such as those connected to the use of medical devices,
are introduced through GSPRs and must be addressed by the documents referenced in this section of the Technical

SECTION General safety Documentation. TÜV SÜD expects to receive information based on requirements according to ISO EN 14971 for risk

04
management plans, reports, clear overall risk benefit statement as well as other risk management related information
and performance requirements (GSPR) (e.g. use risks or cyber security related information) with the Technical Documentation.

“The Technical Documentation shall contain information for the demonstration of conformity with the general safety
and performance requirements set out in Annex I.”
SECTION Product Verification
06 and Validation
The MDR does not require submission of a checklist, even though checklists are commonly used to provide all
relevant information connected to the General Safety and Performance Requirements (GSPRs). The readers of the According to Section 6 of Annex II, “the documentation shall contain the
Technical Information must be able to understand which GSPRs are applicable and which are not. Manufacturers
must provide reasons if they consider a GSPR to be not applicable; simply identifying said GSPR by “n/a” or “not
results and a critical analysis of all verification and validation tests and/
or studies undertaken to demonstrate conformity of the device with the
To enable improved
applicable” is not considered an explanation. requirements of this Regulation and in particular the applicable GSPR”. understanding
and ensure clear
Other information required in this context are “methods used to demonstrate conformity with the applicable” GSPRs.
Methods in this context include test plans, standards, common specifications or other inputs which explain how a
Per definition, the information to be submitted here goes far beyond mere and unambiguous
test reports. Test reports are used “only” to demonstrate conformity with the
manufacturer approaches a specific GSPR. GSPRs. This section however, covers all results used to demonstrate that the
Technical
device is in conformity with the MDR. To enable improved understanding and Documentation,
In case a manufacturer uses harmonised standards, common specifications (CS) or other solutions, information ensure clear and unambiguous Technical Documentation, manufacturers must manufacturers
about these elements must be included in the Technical Documentation. consider that information providing this level of detail must be readable and
understandable for the reviewer. While a simple list of all tests and studies
must consider that
To facilitate locating the evidence of conformity with the harmonised standards, CS or other solutions, under Annex performed together with all verification and validation results will not satisfy information providing
II, Section 4, lit. d manufacturers must provide the precise identify of the controlled document that offers such this requirement, a list or table might prove helpful to reference information. this level of detail
evidence of conformity and include a cross-reference to the exact location of such evidence in the full Technical
Documentation.
Elements addressed in previous sections of the Technical Documentation must be readable
might be useful for clear referencing, e. g. novel design features and the results
of verification, validation and studies associated with these features may be of
and understandable
specific interest to the reviewer. for the reviewer.

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Section 6.1 requires pre-clinical and clinical data to be part of the Technical Documentation and defines such data as
follows: “results of tests such as engineering, laboratory, simulated use and animal tests, and evaluation of published
literature applicable to the device”.

The definition in this section goes beyond the principle of providing pre-clinical data from animal studies only,
and lays down the information that needs to be provided: “detailed information regarding test design, complete
test or study protocols, methods and data analysis, in addition to data summaries and test conclusion regarding in
particular:
§ The biocompatibility (…)
§ Physical, chemical and microbiological characterisation
§ Electrical safety and electromagnetic compatibility
§ Software verification and validation (…)
§ Stability, including shelf life
§ Performance and safety”

If no new testing has been undertaken for a new device because the manufacturer decided to use testing from
a predecessor device, the reasons underlying this decision shall be explained and supported with documented
evidence of the predecessor device in the Technical Documentation.

Sections 6 and 4 are closely related to each other and information provided on GSPR and on verification and
validation will overlap widely.

Section 6.2 lists additional special requirements for specific devices, such as devices incorporating medicinal
substances, devices utilising material of human or animal origin, and other specific devices. Where a TÜV SÜD
assessment report is available that already covers the assessment of individual elements of an ongoing conformity
assessment a clear reference to that TÜV SÜD report (by report number) shall be provided to facilitate the
assessment. Please note that an MDR conformity assessment is a completely new assessment of the medical device
in question and information from early AIMDD/MDD assessments of the same device cannot simply be transfered
over to the MDR assessment.

In order to comply to the overall requirements for a readily searchable Technical Documentation all information IMPORTANT NOTICE
provided in this section - as in all previous sections - must be provided in a format that allows searching and thus Technical Documentation according to the Medical Device Regulation (EU) 2017/745
Revision: 0
requires Optical Character Recognition for PDFs. Effective date: 10 June 2020

Files that are provided here must show evidence that they are controlled records and that they have been properly
released in the document control system either by means of signature (handwritten or digital) or by other means COPYRIGHT NOTICE
The information contained in this document represents the current view of TÜV SÜD on the issues discussed as of the date of publication. Because TÜV SÜD must respond to changing market
implemented in your document control system. An evidence without proof of proper document control cannot be part
conditions, it should not be interpreted to be a commitment on the part of TÜV SÜD, and TÜV SÜD cannot guarantee the accuracy of any information presented after the date of publication.
of the conformity assessment report at TÜV SÜD and will thus not be acceptable. This guideline is for informational purposes only. TÜV SÜD makes no warranties, express, implied or statutory, as to the information in this document. Complying with all applicable
copyright laws is the responsibility of the user. Without limiting the rights under copyright, no part of this document may be reproduced, stored in or introduced into a retrieval system, or
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