New MIR 7.3.1 form mandatory from November 2025
The European Commission has released the new Manufacturer Incident Report [...]
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 [...]
UDI-DI mandatory from May 26, 2025: A guide for manufacturers
An important deadline is coming up under the EU Medical [...]
Clinical Evaluation Report (CER) for MDR: Structure, Strategy, and Compliance
Understanding the Clinical Evaluation Report (CER) When it comes to [...]
