News and Updates
What is the IFU and why is it crucial for medical devices?
When it comes to medical devices, ensuring safety, compliance, and correct usage is crucial. One key document that supports these aspects is the Instructions for Use (IFU). But what is an IFU for medical devices, and why is it [...]
Discover how to register your medical devices in Europe: an essential guide for manufacturers outside the EU!
Are you a manufacturer outside the EU and wondering how the medical device registration process works in Europe? Here’s an essential overview to guide you through the regulatory system! Step 1: Actor Registration The first step is providing key information [...]
Clinical Research in Medical Devices: What Role Does the Manufacturer Play?
Clinical research is fundamental to ensuring the safety and effectiveness of medical devices. But what are the key responsibilities of the manufacturer in this process? Here’s what you need to know: Study Design: The manufacturer must ensure that the study [...]
Exciting news! We’re heading to CMEF, the International Medical Device Fair in Shenzhen!
Join us from October 12 to 15, 2024, at the Shenzhen World Exhibition and Convention Center. Our team is excited to meet industry professionals and discuss how we can support your regulatory needs in the medical device sector. 📌 [...]
Importers or Distributors: Who is Responsible for Medical Device Compliance?
Understanding the responsibilities of importers and distributors is fundamental to ensuring that medical devices comply with EU regulations and safely reach their intended markets. Importer vs. Distributor: What’s the Regulatory Difference? Importer Responsibilities Ensure the device complies with MDR/IVDR [...]
Discover the 6 Steps to Successfully Obtain CE Certification
If you’re developing a medical or in vitro diagnostic device, obtaining the CE mark is essential to enter the European market. Here are the key steps: Classification: Determine the classification of your device (I, IIa, IIb, III for medical devices; [...]
Exciting Update: Istituto Superiore di Sanità Now Accredited for IVDR!
A new key player has been designated for the In Vitro Diagnostic Regulation (IVDR)! The Istituto Superiore di Sanità (NB 0373), based in Italy, has been recently accredited as a notified body. With this addition, the total number of [...]
Innovation and Regulation: How the AI Airlock Sandbox Can Help Medical Device Manufacturers!
Are you a developer or manufacturer of Artificial Intelligence (AI)-based medical devices? Then you should know about the latest opportunity offered by MHRA, the UK’s regulatory agency. They have opened applications for the AI Airlock regulatory sandbox, created to tackle [...]
Global IVD Device Registration: IVDR – 2017/746 Challenges
The IVDR (In Vitro Diagnostic Regulation 2017/746) has drastically changed the regulatory landscape in Europe for IVD devices. The new regulations not only impose stricter risk classifications but also demand rigorous clinical evaluation and post-market surveillance. What should you know [...]
