Europe – MDCG 2023-3 Rev. 2 Questions and Answers on vigilance terms and concepts...
This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical...
USA – FDA issues much-anticipated guidance on pulse oximeters
The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can be...
USA – FDA issues draft guidance on developing and managing AI-enabled devices
The US Food and Drug Administration (FDA) on Monday published a much-anticipated guidance on developing and managing medical devices with artificial intelligence (AI). The...
USA – FDA updates GUDID final guidance
The US Food and Drug Administration (FDA) issued an updated final guidance on Tuesday addressing the submission of unique device identifiers (UDIs) to the...
Canada – Guidance on terms and conditions for class II to IV medical devices
The Food and Drugs Act (FDA) and its regulations give Health Canada the authority to regulate food, drugs (including natural health products), medical devices and cosmetics....
Europe – MDCG 2022-3 rev.1 – Verification of manufactured class D IVDs by notified...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes
the requirements for notified bodies involved in the conformity assessment of applicable classes of...
Canada – Drug and medical device databases
This list of Health Canada's drug and medical device databases briefly describes the information available in each database. It does not provide an in...
Europe – MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class...
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish the requirements for sampling of...
Europe – Interface between the Regulations on clinical trials of medicinal products, medical devices...
In the EU, there are legal requirements for the individual authorisation processes of clinical trials of medicinal products, clinical investigations of medical devices and...
Europe – Commission launches a public consultation and a call for evidence for EU...
The Commission has launched a public consultation and a call for evidence on the EU’s legislation on medical devices and in vitro diagnostic medical devices, as...
