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Technical Files - Essential
Requirements - Risk Analysis - Harmionised StandardsNo matter whether the device is for clinical
investigation, custom-made, class I, IIa, IIb or III, technical documentation (device
master file, technical file, design dossier) is always required. Particular requirements
are given in the MDD, Annex II.3.2 (c) and 4.2, Annex III.3, Annex VII.3, and Annex
VIII.3.1 and 3.2.
Recommended minimum contents
include:
a table of contents
manufacturer's
declaration of conformity
a general description of the
device/device family, including any variants planned
design drawings,
specifications, methods of manufacture, including method of sterilization and validation
data
results of risk analysis
results of calculations,
test reports
reference to applicable harmonized
standards
evidence that the essential
requirements have been met.
MDD Essential Requirements Checklist
clinical data
label and instructions for
use
results of database
researches and copies of relevant literature
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 MDD increased the
responsibility of medical device manufacturers beyond previous regulations by strictly
requiring a formal risk analysis for each device/device family (standard
EN ISO 14971).
In accordance with the new
approach the EU Commission gives mandates and financial support to the European Standards
Committee, CEN, for the development of standards for proving the compliance of products
with the essential requirements of directives. Aft er review whether or not the essential
requirements are covered, 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 (MDD,
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.
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