Noticias y novedades
A new vision for EU governance in the medical device sector: the Notified Bodies’ perspective
The European medical device regulatory framework is at a pivotal moment. Fragmentation, inconsistent implementation, and complex administrative procedures are undermining the intended goals of safety, innovation, and timely market access. In response, a collective of Notified Bodies, represented by NBCG-Med [...]
Can I appoint two different representatives for devices in the same generic group?
No. Under the MDR and MDCG guidance, a manufacturer cannot appoint different authorized representatives for devices that belong to the same generic device group. But what exactly does “same generic group” mean? And how does this apply differently under the [...]
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 [...]
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 [...]
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 [...]
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 [...]
