When does the AI Act apply to medical device software?
The AI Act applies to software intended to fulfil a [...]
Medical device software apps: what are the EU compliance requirements?
To legally publish a medical device software (MDSW) app [...]
What are the new Post-Market Surveillance requirements in the uk from june 2025?
Starting 16 June 2025, new post-market surveillance (PMS) obligations will [...]
What is the EMDN and why does it matter for your medical device?
The EMDN code for medical devices is the official classification [...]
How to write an EU Declaration of Conformity?
What is an EU Declaration of Conformity? An EU Declaration [...]
EU Health Technology Assessment: public consultation and Joint Scientific Consultations now open
The implementation of the EU Health Technology Assessment (HTA) [...]
Sterile gloves, sterile devices and patient transport equipment: what changed in 2025
In 2025, the European Commission introduced a new set of [...]
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 [...]
