The window for watching and waiting on IVDR has firmly closed. For manufacturers of in…
IVD’s
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.
September 2025 deadline for IVDs in the EU: signed agreement for class D legacy devices
Manufacturers of Class D IVDs must sign an agreement with a notified body by 26 September 2025 to benefit from IVDR transitional periods. Learn about the deadlines, requirements, and how Obelis supports the process.
Legacy requirements: 26 May 2025 deadline for in-vitro diagnostic medical devices in the EU
Legacy in-vitro diagnostic devices must comply with IVDR by 26 May 2026. Learn key deadlines, QMS requirements, and how Obelis can support your transition.
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.