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The "Guidance document MEDDEV 2.4/1 Rev 9" issued by the European Committee now
clearly states that bipolar forceps are to be classified as category IIb products.
The Notified Bodies in Germany initially differed from this in the scope of the revised
directive and classified bipolar forceps that may also be used on the central nervous system as
category III products. We therefore classified our products as category III in time and had
them released by our notified body.
Due to the subsequent clarification by the MEDDEV document, we now corrected classification
again to category IIb.
We always strive to make our products correspond to the applicable directives and standards at
all times. In this case, we had to reclassify to category III within the indicated periods to be able
to deliver compliant products.
We regret that this has to be revoked now, but we believe that classification in category IIb is
generally more suitable.
Concerns to the following instruments:
 
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CERTIFICATE Quality Management System Annex II of Directive 93/42/EEC |
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