Ce marking of catheters
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Catheters must go through CE marking to be sold in the European Union. The CE marking technical file includes details about the company, authorized EU representative, device description and features, labeling, manufacturing, sterilization validation, quality control, risk analysis, biocompatibility testing, stability studies, and clinical evaluation to demonstrate the device meets all applicable European directives and harmonized standards. This ensures catheters are safe and effective before being placed in patients.
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Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
When is CE marking mandatory?
CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
Some products are subject to several EU requirements at the same time. You must make sure that your product complies with all the relevant requirements before affixing the CE marking to it. It is forbidden to affix the CE marking to products for which EU specifications do not exist or do not require the affixing of CE marking.
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Technical file for ophthalmic microsurgical knives
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Ce marking of catheters
- 1. CE MARKING OF CATHETERS Malesh M www.i3cglobal.com
- 2. www.i3cglobal.com CE MARKING OF CATHETERS Catheters are very common medical devices which can be inserted in the body to treat diseases or perform a surgical procedure. When we apply for CE Marking for the catheters, we should consider the Requirements as per European Medical Device directive and the standard applicable for the Catheters including testing. Before starting the CE Marking Technical file preparation we have to conform classification and rules in Medical Device directive for catheters and standards applicable directives and harmonized standards
- 3. www.i3cglobal.com 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 Sterilization Process validation reports to prove the efficiency of the clean room and the Sterilizer (EN ISO 11135)
- 4. www.i3cglobal.com 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 are one of the important section in CE Marking The Accelerated Stability study reports to prove the stability of the Device Clinical Evaluation