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...
USA – Final FDA guidance on PCCP includes clarification on version control
The US Food and Drug Administration (FDA) has finalized a long-anticipated guidance on using predetermined change control plans (PCCPs) in submissions for medical devices...
USA – FDA finalizes guidance on 510(k) third-party reviews
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance to assist manufacturers in using an...
USA – The regulatory landscape of ingestible medical devices in the United States
Ingestible medical devices offer novel diagnostic, monitoring, and treatment capabilities. This article explores the regulatory landscape of ingestible devices in the US, highlighting the...
USA – Data Normalization Challenges and Mitigations in Software Bill of Materials (SBOM) Processing:...
The Mitre Corporation says stakeholders should work together to normalize how software bill of materials (SBOMs) are implemented in a newly published white paper,...
Canada – Health Canada digital health head says AI/ML guidance imminent
Health Canada is very close to publishing a much-anticipated guidance on artificial intelligence/machine learning (AI/ML) medical devices and has incorporated pre-determined change control plans...
