Basic Information about the European Directive 93/42/EEC on ...

<strong>Basic</strong> <strong>Information</strong> MDD <strong>93</strong>/<strong>42</strong>/<strong>EEC</strong>
TECHNICAL FILES - RISK ANALYSIS - HARMONIZED STANDARDS
No matter whe<strong>the</strong>r <strong>the</strong> device is for clinical investigation, custom-made, class I, IIa, IIb or III, a technical
documentation (device master file, technical file, design dossier) is always required. Particular
requirements are given in <strong>the</strong> MDD, Annex II.3.2 (c) and 4.2, Annex III.3, Annex VII.3, and Annex
VIII.3.1 and 3.2., Annex V.4.2 and Annex VI.4.2.
The recommended essential content of a technical file is as follows:
• a table of contents
• manufacturer’s declaration of conformity
• a general description of <strong>the</strong> 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 and test reports
• reference to applicable harmonized standards
• evidence that <strong>the</strong> essential requirements have been met
• clinical data
• label and instructions for use
• results of database researches and copies of relevant literature
Guidance is also given in <strong>the</strong> 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 <strong>the</strong> Notified Body, which can
<strong>the</strong>n be referenced in <strong>the</strong> technical file of <strong>the</strong> device manufacturer. Similarly producers of white label/
OEM (Original Equipment Manufacturer) devices may submit documentation.
A guideline regarding <strong>the</strong> procedure for OEM devices is provided by <strong>the</strong> EK-Med resolution „3.09 B 16
Certification of OEM devices”
The MDD increases <strong>the</strong> responsibility of medical device manufacturers beyond previous regulations by
strictly requiring a formal risk analysis for each device/device family. A preferred standard to be used is
<strong>the</strong> harmonized standard EN 14971 <strong>about</strong> <strong>the</strong> risk management of medical devices.
In accordance with <strong>the</strong> new approach <strong>the</strong> EU Commission gives mandates and financial support to <strong>the</strong>
<strong>European</strong> Standards Committee, CEN/CENELEC, for <strong>the</strong> development of standards for proving <strong>the</strong>
compliance of products with <strong>the</strong> essential requirements of directives. After review whe<strong>the</strong>r or not <strong>the</strong>
essential requirements are covered, <strong>the</strong> Commission decides <strong>about</strong> <strong>the</strong> publication of <strong>the</strong> reference of
such standards in <strong>the</strong> Official Journal of <strong>the</strong> <strong>European</strong> Community. By publication of <strong>the</strong> reference
<strong>the</strong>se standards achieve <strong>the</strong> status of a harmonized standard. Manufacturers, who observe <strong>the</strong>
harmonized standards are presumed, that <strong>the</strong>ir products are in compliance with relevant essential
requirements (MDD, Article 5), too. Harmonized standards are still voluntary; where <strong>the</strong> manufacturer
does not apply a harmonized standard he has to document <strong>the</strong> alternative solutions adopted to meet
<strong>the</strong> essential requirements of <strong>the</strong> directive.
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