Navigating the Dual Regulatory Framework: MDR/IVDR and the EU Artificial Intelligence ActFor manufacturers of AI-enabled medical devices in the European market, understanding the interplay between the Medical Devices Regulation (MDR), …
In the world of medical devices, a well-structured Post-Market Surveillance (PMS) Plan is essential for ensuring safety, performance, and regulatory compliance. But what exactly makes a PMS plan actionable and …
Are you navigating Post-Market Surveillance (PMS) and Periodic Safety Update Reports (PSUR) requirements under the EU Medical Device Regulation (MDR)? You’re in the right place! Let’s break down these essential …
Post-market surveillance (PMS) is an essential part of the lifecycle for medical devices. It ensures ongoing safety, effectiveness, and compliance once a product hits the market. Let’s break down why …
The regulation of medical devices in Canada is governed by the Medical Devices Regulations, established under the authority of the Food and Drugs Act. These regulations outline the requirements …
As we mark the occasion of the 6th anniversary of the entering into force of the European Medical Devices Regulation (MDR) and In Vitro Medical Device Regulation (IVDR) , we …
Introduction: Medical devices have revolutionized the healthcare industry by providing advanced and innovative solutions to diagnose, treat, and manage various medical conditions. As medical devices play a vital role in …
The European Commission has Amended the Regulation (EU) 2017/745 on medical devices MDR and regulation (EU) 2017/746 on in Vitro Medical Devices IVDR, due to the existing limitations in the …
The European Union is taking several measures to address concerns regarding the safety and performance of medical devices in the market. There have been fears of a shortage of medical …
The Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) of the European Parliament and Council establish a stronger regulatory framework for medical devices and in vitro diagnostic medical devices. …
