MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices
The MDCG has recently published a guidance concerning post-market surveillance requirements for Medical Device and IVD’s. Unless otherwise specified, this guidance applies to all medical devices (MDs) and in vitro diagnostic medical devices (IVDs). To offer some background to this guidance document, Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in ...
MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
The MDCG has recently published a guidance document concerning BtX, commonly known as break through devices. To offer some background to this guidance document, a medical device (MD) or in vitro diagnostic (IVD) may be designated as a breakthrough device (BtX) if it represents a significant innovation that offers a novel diagnostic or therapeutic solution ...
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 ...
Building a Compliant QMS Under EU MDR
Establishing a robust Quality Management System (QMS) is a cornerstone of regulatory compliance for medical device manufacturers operating in the European Union. The EU Medical Device Regulation (MDR) (Regulation (EU) 2017/745) requires every manufacturer to implement and maintain a QMS covering the entire lifecycle of their devices—from design and development through post-market activities. While the ...
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 ...
MDCG Releases Draft Guidance on Trend Reporting
The MDCG has released a draft guidance document with regard to Trend Reporting, currently numbered as MDCG 2025-XX. To provide context for this release, the draft guidance document MDCG 2025-XX has been developed to explain and clarify key aspects of Trend reporting as outlined in Article 88 of Regulation (EU) 2017/745 on medical devices (MDR) ...
UPDATE: Manual on Borderline and Classification
The Manual on Borderline and Classifications has recently been updated. To offer some background, this document, initially published in 2022, intends to aid manufacturers determine whether a borderline product qualifies as a medical device or an in vitro diagnostic medical device (IVD) and how it should be classified by risk. The recent update sees the ...
Guidance on Custom-Made Devices
The Medical Device Regulation 2017/745 defines a ‘custom-made device’ as any device which is specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications. This authorised person gives specific design characteristics provided under their responsibility. Moreover, such a custom-made device would be exclusive ...
UPDATE: MDCG 2024-14 – rev.1 – Guidance on the implementation of the Master UDI-DI solution for contact lenses
The MDCG guidance document 2024-14 has recently been updated to reflect regulatory changes. This document provides clarification on the application of the Master UDI-DI for contact lenses under the EU Medical Devices Regulation (MDR). To offer some background to this document, the Unique Device Identification (UDI) system, as outlined in Article 27 of Regulation (EU) ...
