IV Catheters and Peripheral Catheters

Difference between IV Catheters and Peripheral Catheters

 

Device name: Peripheral Vascular Catheters

MDR 2017/745:

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.

Conformity Assessment:

  1. Annex II and Annex III AND Chapter I & III of Annex IX

  

OR

 

  1. Annex II and Annex III AND Annex X + Annex XI Part A (Production Quality Assurance)

 

OR

 

  1. 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

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