ANNEX II (PART 1)

Technical documentation

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 in this Annex.

1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES

1.1. Device description and specification

(a)product or trade name and a general description of the device
including its intended purpose and intended users;
(b)the Basic UDI-DI as referred to in Part C of Annex VI assigned by
the manufacturer to the device in question, as soon as identificationof this device becomes based on a UDI system, or otherwise a clear
identification by means of product code, catalogue number or otherunambiguous reference allowing traceability;
(c)the intended patient population and medical conditions to be
diagnosed, treated and/or monitored and other considerations such
as patient selection criteria, indications, contra-indications,
warnings;
(d)principles of operation of the device and its mode of action,
scientifically demonstrated if necessary;
(e)the rationale for the qualification of the product as a device;
(f)the risk class of the device and the justification for the classification
rule(s) applied in accordance with Annex VIII;
(g)an explanation of any novel features;
(h)a description of the accessories for a device, other devices and otherproducts that are not devices, which are intended to be used in
combination with it;
(i)a description or complete list of the various configurations/variants
of the device that are intended to be made available on the market;
(j)a general description of the key functional elements, e.g. its parts/
components (including software if appropriate), its formulation, its
composition, its functionality and, where relevant, its qualitative and quantitative composition. Where appropriate, this shall include
labelled pictorial representations (e.g. diagrams, photographs, and
drawings), clearly indicating key parts/components, including
sufficient explanation to understand the drawings and diagrams;
(k)a description of the raw materials incorporated into key functional
elements and those making either direct contact with the human
body or indirect contact with the body, e.g., during extracorporeal
circulation of body fluids;
(l)technical specifications, such as features, dimensions and
performance attributes, of the device and any variants/
configurations and accessories that would typically appear in the
product specification made available to the user, for example in
brochures, catalogues and similar publications.

1.2. Reference to previous and similar generations of the device

(a)an overview of the previous generation or generations of the deviceproduced by the manufacturer, where such devices exist;
(b)an overview of identified similar devices available on the Union or
international markets, where such devices exist.

2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER

A complete set of:

the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of
specific management conditions, in the languages accepted in the
Member States where the device is envisaged to be sold; and
the instructions for use in the languages accepted in the Member
States where the device is envisaged to be sold.

3. DESIGN AND MANUFACTURING INFORMATION

(a)information to allow the design stages applied to the device to be
understood;
(b)complete information and specifications, including the
manufacturing processes and their validation, their adjuvants, the
continuous monitoring and the final product testing. Data shall be
fully included in the technical documentation;
(c)identification of all sites, including suppliers and sub-contractors,
where design and manufacturing activities are performed.

4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall include:

(a)the general safety and performance requirements that apply to the
device and an explanation as to why others do not apply;
(b)the method or methods used to demonstrate conformity with each
applicable general safety and performance requirement;
(c)the harmonised standards, CS or other solutions applied; and
(d)the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method
applied to demonstrate conformity with the general safety and
performance requirements. The information referred to under this
point shall incorporate 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

The documentation shall contain information on:

(a)the benefit-risk analysis referred to in Sections 1 and 8 of Annex I,
and
(b)the solutions adopted and the results of the risk management
referred to in Section 3 of Annex I.

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