Marking Medical Devices

Unique Device Identification: Direct Marking of Devices

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-direct-marking-devices

Under 21 CFR 801.45, " [a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is...

General Device Labeling Requirements | FDA

https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements

If a manufacturer knows or has information indicating that this device is to be used for conditions or purposes other than which it was intended, he is required to provide …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

Jan 25, 2023

CE Marking for Medical Devices - Intertek

https://www.intertek.com/medical/ce-marking/

8-Step Process Navigating the CE marking process does not have to be painstaking. In fact, Intertek makes it as easy as the following steps: Classify your product - Class I, IIa, …

How to properly label a medical device according to the …

https://mdrregulator.com/news/how-to-properly-label-a-medical-device-mdr-2017-745

UKCA Marking: Fact Sheet for Medical Devices & IVDs

https://casusconsulting.com/ukca-marking-medical-devices-ivds/

The MHRA’s guidance Regulating Medical Devices in the UK states: “If you already have a valid CE marking on your device, you are not required to re-label the …

CE Marking of Medical Devices | mdi Europa

https://mdi-europa.com/ce-marking/

With the new Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices (MDR) and in vitro diagnostic medical devices (IVDR) replacing the Medical Devices Directive …

Laser Marking Medical Devices and Packaging

https://www.mddionline.com/news/laser-marking-medical-devices-and-packaging

Three basic types of laser marking systems commonly mark medical products: steered-beam laser writing yttrium aluminum garnet (YAG) lasers, imaged …

CE Marking for Medical Device Software - Jama Software

https://www.jamasoftware.com/blog/ce-marking-for-medical-device-software-a-step-by-step-guide

How to do CE marking via self-certification? 1: IMPLEMENT A QUALITY MANAGEMENT SYSTEM. As you determine the classification of your Medical Device …

CE Marking of Medical Devices in accordance with MDR

https://www.kiwa.com/en/service2/certification/marking-ce-mdr-medical-devices/

Medical Devices are an heterogeneous category of products, such as active equipment, orthopaedic implants, reusable instruments, substances and materials, software, and …