EU Compliance for Medical and IVD Devices

EU PMS requirements for medical devices under scrutiny of Dutch authority

Dutch audits reveal non-compliance with EU post-market surveillance (PMS) requirements for medical devices. Learn how to strengthen PMS systems for compliance and safety.

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.

Healthcare

Product Categories

Medical Devices

In-Vitro Diagnostics

Aesthetic Devices

News from within the industry