European MDR & Reusable Endoscopes

New rules mean new processes
HubSpot Video
 
With the introduction of Regulation EU MDR 2017/745, reusable rigid endoscopes are now class I reusable medical devices (class Ir).
Reusable rigid endoscopes deteriorate over time due to sterilization and wear.
There are now stricter requirements for the conformity assessment procedure for these products. 



Compliance groen-01

Stricter Compliance

For Class Ir products that are both reusable surgical instruments and have a measurement function, the effects of reprocessing on the measurement function must be evaluated and documented. 
 
That means that hospitals, repair centres and reprocessing companies need to set up their own functional test process to be compliant.
 
Simply be compliant?
Just download our template checklist via the form.
Fill in the blanks, scan and save the file as PDF.
Repair needed? Just turn the page and send it in to your repair company!
 
 

Download Checklist