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.
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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.
26 September 2024: last call for manufacturers of legacy devices
Ensure your medical devices remain compliant by the upcoming 26 September 2024 deadline. Manufacturers must finalize agreements with notified bodies for MDR CE Certification to retain the legacy status of their devices.
Extended IVDR legacy period officially published
On 9 July 2024, the Official Journal of the EU published Regulation (EU) 2024/1860, amending the medical devices Regulations (MDR and IVDR). This introduces an extended legacy period for IVDs, effective immediately.
European Parliament votes in favour of new IVDR legacy period and EUDAMED roll-out plan
Stay informed on upcoming cosmetic regulatory changes. Learn about the deadlines and new requirements for compliance in 2024.
How to prepare for the proposed extension for IVD medical devices
The EU’s proposed extension for IVD medical devices aims to prevent shortages. Manufacturers must prepare by meeting IVDR requirements promptly.
Main regulatory developments to follow in 2024
Find out the 2024 updates regarding Medical devices, In-Vitro diagnostics, cosmetics, construction products, toys and more!
New Free Sales Certificate under MDR & IVDR for EU non-EU manufacturers!
The Belgian competent authority (AFMPS/FAGG) has updated the form for the Free Sales Certificates (FSC) under the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR).