Authorized and Legal Representative: key roles for compliance
In the global regulatory environment for medical and in vitro [...]
Why the UK is moving toward EU-aligned standards for IVDs
The UK’s decision to adopt EU Common Specifications for high-risk [...]
When is the Master UDI-DI mandatory for contact lenses and spectacle frames?
The Master UDI-DI will become mandatory for spectacle frames, spectacle [...]
India strengthens its regulatory presence in Andhra Pradesh: what it means for manufacturers
India has announced the designation of the first regulatory body [...]
New EU regulation on e-IFU: what changes for medical devices?
On 25 June 2025, the European Commission published a [...]
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 [...]
