News and Updates

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). [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

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, [...]

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. [...]

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 [...]