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Technical Files - Essential
Requirements - Harmonised Standards - CTS
No matter whether the device is for performance evaluation, a device for self-testing, a
product according to Annex II (List A or B) or another in-vitro diagnostic device in the
sense of the IVDD technical documentation (device master file, technical file , design
dossier) is always required. Particular requirements are given in Annex III for all of the
devices except the devices for performance evaluation, which are covered by Annex VIII.
The recommended minimum
contents of technical documentation according to Annex III is as follows:
a table of contents,
manufacturer's declaration
of conformity. A multi-lingual sample may be downloaded from the following link:
Declaration of Conformity
a general description of the
device/device family, including any variants planned,
design information,
including the determination of the characteristics of the basic materials, characteristics
and limitation of the perform ance of the devices, methods of manufacture and, in the case
of instruments, design drawings, diagrams of components, sub-assemblies, circuits, etc.,
the descriptions and
explainations necessary to understand the abovementioned characteristics, drawings and
diagrams and the operation of the product,
in the case of devices
containing tissues of human origin or substances derived from such tissue, information on
the origin of such material and on the conditions in which it was collected,
results of risk- or danger-
analysis,
listing of the applied or
partially applied harmonized
standards,
statement of observence to
the Common Technical Specifications (CTS),
evidence that the essential
requirements, Annex I, have been met.
IVDD Essential Requirements Checklist
in the case of sterile
products or products with a special microbiological state or state of cleanliness, a
description of the procedures used,
evidence of the
compatibility with other products,
test reports,
adequate performance
evaluation data showing the performances claimed by the manufacturer and supported by a
reference measurement system (when available), with information on the reference methods,
the reference materials, the known reference values, the accu racy and measurement units
used; such data should originate from studies in a clinical or other appropiate
environment or result from relevent biographical references,
label and instructions for
use,
the results of stability
studies,
- documentation concerning the quality
assurance system (or references to such).
Guidance is also given in the Notified
Bodies Medical Devices (NB-MED) Recommendation document
(NB-MED/2.5.1/Rec
5) 'Technical documentation'.
Raw material manufacturers
or subcontractors may submit master files to the Notified Body, which can then be
referenced in the technical file of the device manufacturer. Similarly producers of white
label / OEM (Original Equipment Manufacturer) devices ma y submit documentation.
The IVDD increases
the responsibility of medical device manufacturers beyond previous regulations by strictly
requiring a formal risk analysis for each device/device family. A preferred standard to
use is the EN ISO 14971.
In accordance with the new
approach the EU Commission gives mandates and financial support to the European Standards
Committee, CEN/CENELEC, for the development of standards for proving the compliance of
products with the essential requirements of directi ves. After review whether or not the
essential requirements are cov ered, the Commission decides about the publication of the
reference of such standards in the Official Journal of the European Communities. By
publication of the reference these standards achieve the status of a harmonized standard.
Manufacturers following the relevant harmonized standards are guaranteed the presumption
that their products (or quality management system) meet the relevant essential
requirements (IVDD, Article 5). Harmonized standards are still voluntary. Where the
manufacturer does not apply a harmonized standard he has to document the solutions adopted
to meet the essential requirements of the directive.
A new aspect in the field
of medical devices are the Common Technical Specifications for certain in vitro diagnostic
devices. Manaufacturers following these relevant CTS are guaranteed the presumption of
compliance with the essential requirements (IVDD, A rticle 5). By non-compliance with the
CTS, if for duly justified reasons, manufacturers must adopt solutions of a level at least
equivalent thereto. CTS are drawn up for the devices in List A of Annex II and, where
necessary, the devices in List B of Annex II. In these specifications appriopiate
performance evaluation and re-evaluation criteria, batch release criteria, reference
methods and reference materials are established. The CTS are elaborated under the
responsibility of the European Commission and published in the Official Journal of the
European Communities.
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