The assumption is understandable: data has been entered, the system has accepted it, something is…
Medical devices and healthcare
IVDR Readiness in 2026: Why Delayed Operational Setup Creates Major Risks
The window for watching and waiting on IVDR has firmly closed. For manufacturers of in…
How to Approach the Final Days Before the EUDAMED 2026 Deadline in May?
For manufacturers, authorised representatives, and distributors of medical devices and IVDs in the EU, the May deadline represents the moment when full EUDAMED requirements take effect across all relevant modules. With just 60 days remaining, the time for gradual preparation has effectively passed.
This article outlines the key actions still required, highlights where organisations most often fall short, and provides guidance on navigating the final stretch before the EUDAMED deadline without making costly mistakes.
EU Proposal to simplify MDR and IVDR: what it is and why it matters
The EU has unveiled a proposal to simplify the MDR and IVDR framework, introducing updates designed to ease compliance and support innovation. Here’s what’s changing and what manufacturers need to do next.
EUDAMED becomes mandatory on 28 May 2026: deadlines for actor, device, and certificate registrations
EUDAMED becomes mandatory on 28 May 2026. Discover key deadlines for actor, device, and certificate registrations under MDR and IVDR, and how to prepare.
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…