TEAM NB Publish Position Paper on Demonstration of Safety and Performance for Combinatorial Use of Reagent Devices with other devices or Equipment
Team-NB has published a new guidance document outlining harmonised Notified Body expectations for demonstrating the safety and performance of reagent devices intended for use in combination with other devices, equipment, or instruments. The document clarifies key considerations for ensuring compliance with Regulation (EU) 2017/746 (IVDR). It is intended to support and complement the existing Team-NB ...
Team NB Publish Position Paper on MDR/IVDR Revision
Team-NB has released a position paper addressing the European Commission’s proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The paper acknowledges that the proposed changes present opportunities to enhance predictability, transparency, and efficiency within the conformity assessment process. Notified Bodies (NBs) broadly support these objectives and recognise that the ...
Proposal for a Regulation to Simplify Rules on Medical and In Vitro Diagnostic Devices
On the 16th of December, the EU published their plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices. This proposal seeks to streamline and future-proof the EU regulatory framework for medical devices and in vitro diagnostics. Its primary objective is to simplify applicable rules, reduce administrative burdens ...
EUDAMED to Become Mandatory as from 28th May 2026
A Commission Decision entering into force on 27 November confirmed that certain electronic systems meet their required functional specifications. This decision has triggered a six-month transition period, as outlined in the Regulation governing EUDAMED’s gradual roll-out. This would mean that the following modules will become mandatory 6 months after this publication. This would make the ...
Update to IVD Classification Guidance to Strengthen Clarity
Advena understands that the Medical Device Coordination Group (MDCG) is currently revising the guidance document MDCG 2020-16 rev.4 – Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. This update is part of ongoing efforts to enhance clarity and improve consistency across EU medical device guidance. The current revision focuses ...
WHO Publish Second Edition of Development of Medical Device Policies
The first edition of the Development of Medical Devices Policies was published in 2011. This second edition has been updated to reflect the global shift from the Millennium Development Goals to the Sustainable Development Goals, ensuring alignment with today’s health priorities. New sections have been introduced to address emerging public health challenges, including sustainability, digital ...
EUDAMED Training Updates and Key Implementation Timelines
Over the past few months, a member of the Advena Team has participated in several training sessions and workshops organized by the European Commission focusing on the implementation of EUDAMED — the European Database on Medical Devices. These sessions provided valuable insights into the system’s structure, functionality, and the upcoming regulatory requirements for economic operators. ...
New Notified Body has been Designated under IVDR
There has been a new notified body that have been designated under the IVDR. The new notified body: SGS FIMKO OY is from Finland. This new addition brings the total number of notified bodies under the IVDR to 19. More information about this notified body can be found using the following link
Deadline to Make use of New MIR Template has been Delayed
The deadline for the mandatory use of the New MIR Template has been postponed. Previously, we reported that the new MIR form would be mandatory starting November 1, 2025. However, this has now been delayed due to indications that a revised version of the form is forthcoming. The new mandatory implementation date will be four ...
UPDATE: TEAM NB Update Position Paper regarding Technical Documentation under IVDR.
TEAM NB has recently updated their Position Paper “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746”. To offer some background to this document, TEAM NB has developed unified best practice guidance to clarify expectations for technical documentation submissions under the ...
