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General
CEBEC has been notified by the Belgian authorities to the European
Commission as a body recognised for performing the assessment procedures
foreseen by the art. 5 of the Belgian Royal Decree of 18 March 1999 transposing
the Directive 93/42/EEC on medical devices. This notification concerns
the annexes II (full quality assurance system), III (EC
type-examination), IV (EC verification), V (production quality
assurance) and VI (product quality assurance). It covers:
- Active medical devices but those emitting ionising radiations and
those designed to image in-vivo the dispersion of
radiopharmaceutical products
- Non invasive devices limited to those designed:
- to immobilise or to apply a force or pressure on the body or
parts of the body
- to stand patient bodies (beds...)
- for miscellaneous uses (stethoscopes, non invasive
electrodes...)
- Re-usable surgical instruments
It also concerns the verification of mechanical, electrical and
electromechanical aspects of medical devices of classes I, IIa and IIb
using ionising radiations according to the annexes III and IV but for
the nuclear aspects.
Regulation
Click here to access our page on the regulation of
medical devices in the European Economic Area - EEA.
More details can be obtained from the website of the European Commission. Click
here to access the related pages.
Information
For further information please contact:
CEBEC
Avenue Frans Van Kalken, 9A/box 1
BE - 1070 BRUSSELS (Belgium)
Tel: + 32 (0)2 556 00 20
Fax: + 32 (0)2 556 00 36
CEBEC provides market access
21/10/2004
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