CE marking for Class I medical devices: Can I self-certify my product?
Many manufacturers assume that Class I medical devices can [...]
How to register a medical device or IVD in Saudi Arabia: SFDA registration process explained
Getting started with SFDA registration If you plan to market [...]
New MIR 7.3.1 form mandatory from November 2025
The European Commission has released the new Manufacturer Incident [...]
How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers
If you are a medical device or IVD manufacturer based [...]
DNV joins the IVDR framework as a Notified Body: A new option for IVD manufacturers
DNV designated as IVDR Notified Body The list of IVDR [...]
Switzerland plans new pathway for non-EU medical devices
Switzerland is preparing to introduce a more flexible regulatory framework [...]
SGS Belgium designated as IVDR Notified Body: What it means for IVD manufacturers
A new designation strengthening EU capacity for IVDR conformity assessments [...]
How to comply with regulated cosmetic ingredients in Switzerland
Switzerland has its own legal framework for cosmetic products, which [...]
Formal Application for Class D and IVDD Devices: key requirements before May 26, 2025
Much has already been said about the importance of UDI-DI [...]
IVDR compliance deadline: how to prepare your Quality Management System (QMS) by May 26, 2025
With the entry into force of the Regulation (EU) 2017/746 [...]
