EU Compliance for Medical and IVD Devices

Anticipating and notifying supply interruptions or discontinuations under article 10a MDR and IVDR

Learn about the new Article 10a under EU MDR and IVDR, requiring manufacturers to notify authorities and stakeholders of potential medical device or IVD supply interruptions. Understand the scope, notification process, and exemptions, as well as how to comply with these regulations to ensure patient safety and continuity of care.

Distance sales devices: a look at EU requirements

Distance sales devices, sold through online platforms, must meet specific regulations outlined in Article 6 of the MDR and IVDR to ensure safety and performance. This includes devices used for remote healthcare services, even if not directly sold within the EU.

Mutual recognition of regulations between the EU and Switzerland

Discover how the EU and Switzerland maintain strong trade relations through mutual regulation agreements, enabling smoother market access for many products.

Healthcare

Product Categories

Medical Devices

In-Vitro Diagnostics

Aesthetic Devices

News from within the industry