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

Labelling

Home
Blog Standard
Tag: Labelling
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
Global Labelling Requirements
05Feb 2024
EU, Blogs, FDA, General Information, Regulations, UK, USA admin Comments: 0

Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)? 1. A Label is the written, printed, or graphic information that goes on the packaging of the medical device. 2. Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document. 3. Labelling is the content that goes on the Label or IFUs. What are the minimum requirements for labeling? The ISO has published many standard...
Read More

Enquiry Now

    This will close in 0 seconds