6 common mistakes in MDR technical documentation (and how to avoid them)
Creating technical documentation for MDR compliance can be challenging. Although [...]
CDSCO cosmetic product registration cancelled: what this case teaches manufacturers
On May 20, 2025, the Central Drugs Standard Control Organisation [...]
Legacy devices: no need to update the label with a UDI-DI
If you are still placing legacy medical devices on the [...]
PRRC MDR IVDR: role, requirements and compliance duties
What is the role of the PRRC? The person responsible [...]
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 [...]
