Basic Information about the European Directive 93/42/EEC on ...
Basic Information about the European Directive 93/42/EEC on ...
Basic Information about the European Directive 93/42/EEC on ...
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<str<strong>on</strong>g>Basic</str<strong>on</strong>g> <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> MDD <str<strong>on</strong>g>93</str<strong>on</strong>g>/<str<strong>on</strong>g>42</str<strong>on</strong>g>/<str<strong>on</strong>g>EEC</str<strong>on</strong>g><br />
THE EUROPEAN MEDICAL DEVICE VIGILANCE SYSTEM<br />
Article 10 of <str<strong>on</strong>g>the</str<strong>on</strong>g> MDD requires Member States to take <str<strong>on</strong>g>the</str<strong>on</strong>g> necessary steps to ensure that any<br />
informati<strong>on</strong> brought to <str<strong>on</strong>g>the</str<strong>on</strong>g>ir knowledge <str<strong>on</strong>g>about</str<strong>on</strong>g><br />
• any malfuncti<strong>on</strong> or deteriorati<strong>on</strong> in <str<strong>on</strong>g>the</str<strong>on</strong>g> characteristics and/or performance of a device, as well<br />
as any inadequacy in <str<strong>on</strong>g>the</str<strong>on</strong>g> labeling or <str<strong>on</strong>g>the</str<strong>on</strong>g> instructi<strong>on</strong>s for use which might lead or have led to<br />
<str<strong>on</strong>g>the</str<strong>on</strong>g> death of a patient or user or to a serious deteriorati<strong>on</strong> in his state of health,<br />
• any technical or medical reas<strong>on</strong> in relati<strong>on</strong> to <str<strong>on</strong>g>the</str<strong>on</strong>g> characteristics or performance of a device for<br />
<str<strong>on</strong>g>the</str<strong>on</strong>g> reas<strong>on</strong>s referred to above, leading to a systematic recall of devices of <str<strong>on</strong>g>the</str<strong>on</strong>g> same type by<br />
<str<strong>on</strong>g>the</str<strong>on</strong>g> manufacturer<br />
is recorded and evaluated centrally. Details of <str<strong>on</strong>g>the</str<strong>on</strong>g> medical device vigilance system and <str<strong>on</strong>g>the</str<strong>on</strong>g> necessary<br />
activities of <str<strong>on</strong>g>the</str<strong>on</strong>g> manufacturers, Competent Authorities, Commissi<strong>on</strong>, Notified Bodies, and users are<br />
regulated in <str<strong>on</strong>g>the</str<strong>on</strong>g> document MEDDEV 2.12/1: 'Guidelines <strong>on</strong> a medical device vigilance system'.<br />
In c<strong>on</strong>trast to <str<strong>on</strong>g>the</str<strong>on</strong>g> medical device reporting (MDR) system of <str<strong>on</strong>g>the</str<strong>on</strong>g> United States <strong>on</strong>ly serious and<br />
potentially serious problems with devices have to be reported in Europe. Similar to <str<strong>on</strong>g>the</str<strong>on</strong>g> MDR <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
<str<strong>on</strong>g>European</str<strong>on</strong>g> vigilance guideline asks for global reporting of incidents – no matter in which country <str<strong>on</strong>g>the</str<strong>on</strong>g>y<br />
might happen.<br />
The obligati<strong>on</strong> of medical device manufacturers to institute and keep up to date a systematic procedure<br />
to review experience gained from devices in <str<strong>on</strong>g>the</str<strong>on</strong>g> post-producti<strong>on</strong> phase and to implement appropriate<br />
means to apply any necessary corrective acti<strong>on</strong> is regulated in <str<strong>on</strong>g>the</str<strong>on</strong>g> c<strong>on</strong>formity assessment procedures<br />
in <str<strong>on</strong>g>the</str<strong>on</strong>g> Annexes II, IV, V, VI, and VII of <str<strong>on</strong>g>the</str<strong>on</strong>g> MDD. The proper establishment of this post-marketing<br />
surveillance (PMS) system by <str<strong>on</strong>g>the</str<strong>on</strong>g> manufacturer is subject to <str<strong>on</strong>g>the</str<strong>on</strong>g> inspecti<strong>on</strong>s by <str<strong>on</strong>g>the</str<strong>on</strong>g> Notified Body.<br />
Where a Member State ascertains that medical devices, when correctly installed, maintained and used<br />
for <str<strong>on</strong>g>the</str<strong>on</strong>g>ir intended purpose, may compromise <str<strong>on</strong>g>the</str<strong>on</strong>g> health and/or safety of patients, users or, where<br />
applicable, o<str<strong>on</strong>g>the</str<strong>on</strong>g>r pers<strong>on</strong>s, it shall take all appropriate interim measures to withdraw such devices from<br />
<str<strong>on</strong>g>the</str<strong>on</strong>g> market or prohibit or restrict <str<strong>on</strong>g>the</str<strong>on</strong>g>ir being placed <strong>on</strong> <str<strong>on</strong>g>the</str<strong>on</strong>g> market or put into service. The Member State<br />
shall immediately inform <str<strong>on</strong>g>the</str<strong>on</strong>g> Commissi<strong>on</strong> of any such measures, indicating <str<strong>on</strong>g>the</str<strong>on</strong>g> reas<strong>on</strong>s for its decisi<strong>on</strong>.<br />
The Commissi<strong>on</strong> shall c<strong>on</strong>sult, as so<strong>on</strong> as possible, with <str<strong>on</strong>g>the</str<strong>on</strong>g> parties c<strong>on</strong>cerned. Thus <str<strong>on</strong>g>the</str<strong>on</strong>g> safeguard<br />
clause in Article 8 of <str<strong>on</strong>g>the</str<strong>on</strong>g> MDD gives Member States <str<strong>on</strong>g>the</str<strong>on</strong>g> right to intervene immediately even in <str<strong>on</strong>g>the</str<strong>on</strong>g> case<br />
of devices correctly CE-marked, if <str<strong>on</strong>g>the</str<strong>on</strong>g>re is an acute danger for <str<strong>on</strong>g>the</str<strong>on</strong>g> health of patients, users or third<br />
pers<strong>on</strong>s.<br />
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