EUDAMED becomes mandatory on 28 May 2026. Discover key deadlines for actor, device, and certificate registrations under MDR and IVDR, and how to prepare.
Medical devices and healthcare
Revision of the Medical Devices Regulations in the EU
Since 2024, the European Commission has been conducting a targeted evaluation of the EU Medical Devices Regulations (MDR and IVDR). The Parliament as well as many Member States have called for a simplification of the regulations, together with business associations from the medical device sector.
EU IVDR Regulation: What It Is, Compliance Guide & Requirements
The EU In Vitro Diagnostic Regulation (IVDR) formally known as Regulation (EU) 2017/746replaces the former…
EU MDR Regulation Explained: Requirements & Compliance
A number of regulatory requirements must be taken into account when introducing medical devices into…
GDPR and clinical investigations: who is the data controller?
Understand who qualifies as the data controller in clinical investigations under the EU MDR and GDPR. Learn the roles of sponsors and investigators, the implications of joint controllership, and the legal responsibilities tied to personal data processing in clinical trials.
Distribution of Medical Devices in Global Markets
The global medical device industry operates within an increasingly intricate regulatory web. As healthcare innovation…
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.
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.