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 The draft guidance follows years of discussion about concerns that the devices can be...
USA – FDA issues draft guidance on developing and managing AI-enabled devices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....
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...
UK – Medical Devices Regulatory Reform – Roadmap to implementation – Update
A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition...
Europe – MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of...
The Medical Device Coordination Group (MDCG) has introduced new guidance under MDCG 2024-16, streamlining how manufacturers report interruptions or discontinuations in the supply of...
