Trois nouvelles guidances du MDCG en Mars 2020

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...
TGA Updates Guidance on the Testing of Biological Medicines

Australia – Medical device regulation changes

Changes have been made to the regulation of: software-based medical devices prescription spectacle lenses medical devices containing microbial, recombinant, or animal substances medical device...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – Study supporting the monitoring of the availability of medical devices on the...

Commissioned by: The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) via the European Health and Digital Executive Agency (HaDEA) • Aim: To support...

Europe – User guide for micro, small and medium-sized enterprises

This guide has been prepared for micro, small and medium sized enterprises (‘SMEs’) operating in the pharmaceutical sector. Its aim is to facilitate understanding...

International – The global regulatory landscape for AI/ML-enabled medical devices

Digital health has revolutionized the healthcare sector. Artificial intelligence (AI) and machine learning (ML) have gained widespread recognition because of their promising benefits in...

Europe – Q&A Obligation to inform in case of interruption or discontinuation of supply

Introduction – Objectives of the MDR/IVDR amendment The amendment of the MDR and of the IVDR through Regulation (EU) 2024/1860 addresses three topics: 1. Regulation (EU)...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices

A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR)...

USA – Best Practices for Selecting a Predicate Device to Support a Premarket Notification...

FDA developed this document to provide guidance to industry and FDA staff about best practices in selecting a predicate device for premarket notification ...

USA – FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They...

Physicians heavily rely on laboratory tests to make critical decisions about their patients’ care—roughly 70% of healthcare decisions depend on laboratory test results according...

Europe – Request for a scientific opinion on risks for the health associated to...

Article 51(1) of Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council...

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