1. CE MARKING OF SURGICAL
MESH
Malesh M
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2. CE MARKING OF SURGICAL MESH
Surgical sterile mesh is used for the repair of Hernia
or other fascial deficiencies that require the additional
of a reinforcing or bridging material to obtain the
desired surgical result.. Absorbable and Non
absorbable are the two categories. CE Marking
Technical files preparation we have to conform
classification and rules in Medical Device directive for
catheters and standards applicable directives and
harmonized standards
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3. The CE Marking technical file should include
Company Details
Authorized EU Representative Address,
Device description
Device features
Specimen label, should comply with the Requirement
of ISO 15223
Device Manufacturing Details
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4. Sterilization Process validation reports to prove the
efficiency of the clean room and the Sterilizer (EN ISO
11135)
Complete description about the incoming, in process
and final inspection
Quality Control Reports
Risk Analysis as per the standard ISO 14971
The Biocompatibility Test Reports like sensitivity
testing, systemic toxicity etc
The Accelerated Stability study reports to prove the
stability of the Device
Clinical Evaluation
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