Device name: Peripheral Vascular Catheters
Class: Class III, Rule 8: Implantable device and long term surgical invasive device as per Annex VIII
Rule 8: All implantable devices and long-term surgically invasive devices are classified as class IIb.
- Annex II and Annex III AND Chapter I & III of Annex IX
- Annex II and Annex III AND Annex X + Annex XI Part A (Production Quality Assurance)
- Annex II and Annex III AND Annex X + Annex XI Part B (Product Verification)
- Annex II is technical file preparation
- Annex III is documented on post-market surveillance
- Article 32: SSCP (Summary of safety and clinical performance)
Difference between IV Catheters and Peripheral Catheters
Intravenous Catheter or Intravascular Catheter: Intravenous (IV) therapy involves the delivery of medication, blood, or fluids directly into the bloodstream. These are short term or transient use.
Peripherally intravenous catheters are used when a patient requires fluids, medication, nutrients, or chemotherapy for extended periods of time, sometimes till 12 months. This is a long term medical device.
One more possible if the product is just a Peripheral vascular Catheter, it is Class IIb Rule 8
If the product is a Central vascular Catheter, then it’s Class III, Rule 8
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