News and Updates
New EU manual on borderline & classification of medical devices and IVDs
The European Union has released the 4th edition of the Manual on Borderline and Classification for Medical Devices and In Vitro Diagnostic Medical Devices (IVDs). This update provides practical, case-based guidance to help stakeholders determine whether a product falls [...]
Australia’s approach to regulating software-based medical devices
The rapid rise of digital health technologies is transforming healthcare delivery. Software is no longer just an accessory to medical devices, it can operate as a medical device on its own. To guarantee safety and performance, the Therapeutic Goods Administration [...]
Swissdamed UDI Devices module: medical device registration now available
On 18 August 2025, Swissmedic launched the new UDI Devices module in swissdamed, the national database for medical devices in Switzerland. This update makes it possible to register medical devices, in vitro diagnostic medical devices (IVDs), as well as systems [...]
China and Malaysia launch reciprocal medical device reliance pilot programme
On 30 July 2025, the regulatory authorities in China and Malaysia launched a two-month pilot programme to grant companies accelerated access to market for certain medical devices. The pilot phase will end on 30 September 2025. A reciprocal agreement for [...]
Swissmedic information sheet on systems and procedure packs
From 4 August 2025, Swissmedic clarifies the obligations for systems and procedure packs (SPPs) containing at least one medical device in Switzerland and Liechtenstein, under the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). [...]
FDA MDUFA Small Business Benefits: eligibility and reduced fee options
The Medical Device User Fee Amendments (MDUFA) authorize the FDA to collect user fees for certain types of medical device submissions and for the annual establishment registration. For small companies in the sector, these costs can be reduced—or in [...]
MDR and IVDR Certification: Key Insights from the 14th NB Survey
The availability of medical devices in the EU is closely linked to the certification capacity of Notified Bodies (NBs). To monitor this dynamic, the European Commission launched a recurring survey collecting data from all designated NBs under the MDR and [...]
MHRA Early Access: a new pathway for innovative medical devices in the UK
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced the upcoming launch of a new Early Access service to support faster adoption of innovative medical devices, particularly in areas where there is an unmet clinical need. The official [...]
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 [...]
