Catheters are very common medical devices which can be inserted in the body to treat diseases or perform a surgical procedure. Based on the application the Catheters are categorized as Cardiovascular Catheters, Urology Catheters, Gastrointestinal Catheters, Neurovascular Catheters, and Ophthalmic Catheters etc, among this the Urinary Catheters are most popular nowadays.
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
The CE Marking technical file should include following details,
- Company Details,
- Authorized EU Representative Address,
- Legal documents to prove the company details.
- QMS certificates( ISO 13485)
- Device description
- Device features
- Specimen label, should comply with the Requirement of ISO 15223
- Device Manufacturing Details including Process flow chart
- Sterilization Process validation reports to prove the efficiency of the clean room and the Sterilizer(should consider the standard EN ISO 11135standards)
- Complete description about the incoming, in process and final inspection
- QC 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
- A general description about the purchase process.
- Critical raw materials and their approved suppliers.
- Material Safety Data sheath for each Material.
The CE Marking Technical File should submitted to notified body for conformity assessment as per of MDD 93/42/EEC
Malesh M
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