Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook
Call Us Now:
+44 2080667260 sales@omcmedical.com

EU IVDR

Home
Blog Standard
Tag: EU IVDR
13Jul 2024
IVD Cubicdesignz Comments: 0

Labelling and IFU requirements of the New EU IVDR

Information for use (IFU) and labels must be provided with every In-Vitro diagnostic medical device, containing information to identify the device, its manufacturer and any relevant safety and performance information for the user or any other person.     Such information may be found on the device itself, in the packaging, or in the user instructions (IFU), and if the manufacturer has a website, it must be made available and maintained up to date on the website. Updates in Labelli...
Read More
12Jul 2024
EU, EU MDR Cubicdesignz Comments: 0

EU IVDR’s First certification for the type of IVD and Notified Bodies Procedures

A short article based on MDCG 2021-22 guidelines on “first certification for the type of devices and the corresponding procedures to be followed by the Notified Bodies, ” established based on Article 106 of Regulation 2017/745  for Class D IVDR devices. Additionally, this guide talks about the conditions to be followed by the Notified bodies, whether to consult the expert panel for the performance evaluation report of the IVDR devices. According to Article 48(6) of IVDR 2017/746, th...
Read More