The technical documentation and, if applicable, the summary thereof to be

drawn up by the manufacturer shall be presented in a clear, organised,

readily searchable and unambiguous manner and shall include in particular
the elements listed:

1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND

ACCESSORIES
1.1. Device description and specification
Product description and intended Use
▢ Verify that the document includes the product or trade name of the device.
▢ Ensure there is a clear and comprehensive general description of the device's
intended purpose.
▢ Confirm that the intended users of the device are clearly stated.
Unique Device Identifier (UDI) Information
▢ Ensure that the document includes the Basic UDI-DI assigned to the device as per
Part C of Annex VI or another clear identification method.
▢ Check that traceability is maintained through product codes, catalogue numbers,
or other unambiguous references.
Intended Patient Population and Medical Conditions
▢ Verify that the intended patient population and medical conditions for diagnosis,
treatment, and monitoring are clearly specified.
▢ Ensure that patient selection criteria, indications, contra-indications, and
warnings are provided.
Principles of Operation and Mode of Action
▢ Confirm that the document explains the principles of operation for the device.
▢ Ensure that the device's mode of action is scientifically demonstrated if required.
 Rationale for Device Qualification
▢ Verify that the rationale for classifying the product as a medical device is
included.
Device Risk Classification and Justification
▢ Check that the risk class of the device is stated.
▢ Ensure that justifications for the classification rules applied in accordance with
Annex VIII are provided.
Explanation of Novel Features
▢ Confirm that any novel features of the device are explained in detail
Description of Accessories and Complementary Products
▢ Verify that there is a description of accessories intended for use with the device.
▢ Ensure that other devices and products that are not devices but are intended for
combination use with the device are described.
Configurations/Variants of the Device
▢ Check for a description or complete list of various configurations/variants of the
device that will be available on the market.
Description of Key Functional Elements
▢ Confirm that there is a general description of key functional elements, including
parts/components, formulation, composition, functionality, and, if applicable,
qualitative and quantitative composition.
▢ Ensure that labeled pictorial representations (e.g., diagrams, photographs,
drawings) are included, clearly indicating key parts/components.
Raw Materials Information
▢ Verify that the document includes information about raw materials incorporated
into key functional elements, especially those in direct or indirect contact with the
human body.
 Technical Specifications
▢ Confirm that technical specifications, such as features, dimensions, and
performance attributes, are provided for the device, as well as any variants,
configurations, and accessories typically found in product specifications for users.
1.2. Reference to previous and similar generations of the device
Overview of Previous Generation
▢ Confirm that an overview of any previous generation(s) of the device produced by
the manufacturer is included in the documentation.
▢ Ensure that the documentation provides information about the differences or
improvements between the current generation and previous ones, if applicable.
2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
Labeling
▢ Verify that the documentation includes a complete set of labels affixed to the
device and its packaging. This should encompass labels on single unit packaging,
sales packaging, and transport packaging (if applicable), taking into consideration
specific management conditions.
▢ Ensure that the labels are provided in the languages accepted in the Member
States where the device is intended to be sold.
Instructions for Use
▢ Confirm that the documentation includes a complete set of instructions for use.
▢ Ensure that these instructions are provided in the languages accepted in the
Member States where the device is intended to be sold.

3. DESIGN AND MANUFACTURING INFORMATION

Information on Design Stages
▢ Confirm that the documentation includes information that allows understanding of
the design stages applied to the device, including design changes or iterations.
Complete Manufacturing Information and Specifications
▢ Verify that the documentation contains complete information and specifications
about the device, including details about the manufacturing processes.
▢ Ensure that manufacturing processes and their validation are comprehensively
documented.
▢ Check for information regarding any adjuvants used in the manufacturing process.
▢ Confirm that continuous monitoring of the manufacturing process is described.
▢ Ensure that final product testing data are included in the technical documentation.
Identification of Sites
▢ Confirm that all sites involved in design and manufacturing activities related to
the device are clearly identified.
▢ Verify that suppliers and sub-contractors, if any, are also identified.
4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
General Safety and Performance Requirements
▢ Verify that the documentation identifies the general safety and performance
requirements that apply to the device.
▢ Ensure that there is an explanation as to why certain requirements do not apply to
the device based on its intended purpose.
Methods for Demonstrating Conformity
▢ Confirm that the documentation outlines the method or methods used to
demonstrate conformity with each applicable general safety and performance
requirement.
Use of Harmonized Standards and Other Solutions
▢ Verify that the documentation specifies the harmonized standards, common
specifications (CS), or other solutions that have been applied to demonstrate
conformity.
Precise Identity of Controlled Documents
▢ Ensure that the documentation includes the precise identity of controlled
documents that offer evidence of conformity with each harmonized standard, CS,
or other method applied to demonstrate conformity.
▢ Confirm that there is a cross-reference to the location of such evidence within the
full technical documentation and, if applicable, the summary technical
documentation.
5. BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
Benefit-Risk Analysis
▢ Verify that the documentation contains information regarding the benefit-risk
analysis, as referred to in Sections 1 and 8 of Annex I.
▢ Ensure that the analysis includes an assessment of the benefits and risks
associated with the device's use and how these align with the intended purpose.
Risk Management
▢ Confirm that the documentation includes details about the solutions adopted as a
result of risk management, as referred to in Section 3 of Annex I.
▢ Check that the results of the risk management process are documented, including
the identification, assessment, control, and monitoring of risks associated with the
device.
6. PRODUCT VERIFICATION AND VALIDATION
6.1. Pre-clinical and clinical data
Test Results and Literature Evaluation
▢ Verify that the documentation includes the results of tests, such as engineering,
laboratory, simulated use, and animal tests, relevant to the device's pre-clinical
safety and conformity with specifications.
▢ Ensure that the documentation addresses evaluation of published literature
applicable to the device or similar devices, considering their intended purpose.
Detailed Test Information
▢ Confirm that the documentation provides detailed information regarding test
design, complete test or study protocols, and methods of data analysis.
▢ Check that data summaries and test conclusions are included for the following
aspects:
▢Biocompatibility, including material identification for patient or user contact.
▢Physical, chemical, and microbiological characterisation.
▢Electrical safety and electromagnetic compatibility.
▢Software verification and validation, describing the software design and
development process, validation evidence, and results of verification, validation,
and testing.
▢Stability, including shelf life.
▢Device performance and safety.
▢ Ensure that, where applicable, conformity with the provisions of Directive
2004/10/EC is demonstrated.
▢ Check that if no new testing has been conducted, the documentation incorporates
a rationale for this decision, such as previous testing of identical materials.
Clinical Evaluation
▢ Verify that the documentation includes the clinical evaluation report, its updates,
and the clinical evaluation plan as required by Article 61(12) and Part A of Annex
XIV.
Post-Market Clinical Follow-Up (PMCF)
▢ Confirm that the PMCF plan and PMCF evaluation report are included as required
by Part B of Annex XIV.
▢ Ensure that there is a justification provided if PMCF is not applicable.
6.2. Additional information required in specific cases
Incorporation of Medicinal Substance
▢ Verify that if the device incorporates a substance that may be considered a
medicinal product when used separately, a statement indicating this fact is
included in the documentation.
▢ Ensure that the documentation identifies the source of that substance.
▢ Confirm that the documentation contains data on tests conducted to assess the
safety, quality, and usefulness of the substance, considering the device's intended
purpose.
Use of Human or Animal Origin Tissues or Cells
▢ Check if the device is manufactured using tissues, cells, or their derivatives of
human or animal origin, and if it incorporates such materials.
▢ Ensure that a statement indicating this fact is included in the documentation.
Verify that the documentation identifies all materials of human or animal origin
used.
▢ Confirm that detailed information concerning conformity with Sections 13.1. or
13.2. of Annex I is provided, as applicable.
Substances Introduced into the Human Body
▢ Verify that detailed information on studies related to substances or combinations
of substances intended to be introduced into the human body is included in the
documentation.
▢ Ensure that this information covers aspects such as absorption, distribution,
metabolism, excretion, possible interactions, local tolerance, and toxicity.
▢ Confirm that test design, protocols, data analysis methods, data summaries, and
test conclusions are provided.
▢ Check for a justification if such studies are absent.
CMR or Endocrine-Disrupting Substances
▢ Verify that if the device contains CMR (Carcinogenic, Mutagenic, or Toxic for
Reproduction) or endocrine-disrupting substances, the justification referred to in
Section 10.4.2 of Annex I is included in the documentation.
 Sterile or Defined Microbiological Condition Devices
▢ Check if the device is placed on the market in a sterile or defined microbiological
condition.
▢ Ensure that the documentation includes a description of the environmental
conditions for relevant manufacturing steps.
▢ Verify that, in the case of devices placed on the market in a sterile condition, the
documentation provides a description of the methods used for packaging,
sterilization, and maintenance of sterility, including validation reports.
▢ Confirm that the validation report addresses bioburden testing, pyrogen testing,
and, if applicable, testing for sterilant residues.
Devices with Measuring Function
▢ Check if the device has a measuring function.
▢ Ensure that the documentation includes a description of the methods used to
ensure accuracy as specified in the device's specifications.
Devices Connected to Other Devices
▢ Verify if the device is intended to be connected to other device(s) to operate as
intended.
▢ Ensure that the documentation includes a description of this combination or
configuration.
▢ Confirm that there is proof that the combination or configuration conforms to the
general safety and performance requirements when connected to any such
device(s), considering the manufacturer's specified characteristics.
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