Europe – MDCG 2024-8 Rev. 1 Preliminary assessment review template – ...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed...
Europe – MDCG 2024-7 Rev. 1 Preliminary assessment review template – MDR...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed...
Europe – MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus...
The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs)...
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 The draft guidance follows years of discussion about concerns that the devices can be...
USA – FDA issues draft guidance on developing and managing AI-enabled devices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...
