News and Updates
US FDA vs EU MDR: Key differences in medical device classification
Selling a medical device in both the United States and the European Union means navigating two different regulatory systems. Although both rely on risk-based classification, the criteria, terminology, and approval processes vary significantly. Misunderstanding these differences can lead to delays, [...]
Authorized and Legal Representative: key roles for compliance
In the global regulatory environment for medical and in vitro diagnostic devices, manufacturers operating outside a given market are often required to appoint a local representative. Two distinct roles exist in this context: the Authorized Representative and the Legal Representative. [...]
Why the UK is moving toward EU-aligned standards for IVDs
The UK’s decision to adopt EU Common Specifications for high-risk in vitro diagnostic (IVD) devices reflects a regulatory shift toward performance-based requirements and alignment with internationally recognised standards. This approach supports public health objectives, replaces legacy mechanisms such as the [...]
When is the Master UDI-DI mandatory for contact lenses and spectacle frames?
The Master UDI-DI will become mandatory for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles from September 2028, and for contact lenses from 9 November 2026. These deadlines are defined in MDCG 2025-7 and the relevant Delegated Regulations. Master UDI-DI [...]
India strengthens its regulatory presence in Andhra Pradesh: what it means for manufacturers
India has announced the designation of the first regulatory body in the state of Andhra Pradesh authorised to inspect manufacturing facilities for Class A and Class B medical devices. This move brings clear advantages to manufacturers seeking faster, more accessible, [...]
New EU regulation on e-IFU: what changes for medical devices?
On 25 June 2025, the European Commission published a new regulation that allows all medical devices used by healthcare professionals in the EU to be accompanied by instructions for use (IFU) in electronic format. This update expands the use [...]
When does the AI Act apply to medical device software?
The AI Act applies to software intended to fulfil a medical purpose, when it qualifies as an AI system and is part of a medical device or IVD subject to MDR or IVDR. Only those requiring a conformity assessment involving [...]
Medical device software apps: what are the EU compliance requirements?
To legally publish a medical device software (MDSW) app in the EU, manufacturers must ensure full compliance with the MDR or IVDR before making the app available on a platform. This includes providing mandatory product information and aligning with [...]
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 apply to all medical devices placed on the market in Great Britain. These changes affect in vitro diagnostic (IVD) devices, implantables, and all classes of general medical devices. Manufacturers, authorised [...]
