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 ...
Medical Devices and In Vitro Diagnostics – Targeted Revision of EU Rules
The European Commission has launched a new Call for Evidence as part of a targeted initiative to streamline the EU regulatory framework for medical devices—without conducting a full impact assessment. This step builds on ongoing evaluations of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). ...
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: MDR Language Requirements
The EU Commission has updated the MDR Language Requirements Table. To offer some background to this update, the document, initially released in January of 2024, was published to aid manufacturers navigate the language requirements of different member states. The table is very well organised and is segmented per EU Member states making reference to the ...
2025/788 COMMISSION DELEGATED REGULATION (EU) 2025/788 of 16 April 2025 amending Delegated Regulation (EU) 2023/2197 as regards the date of application
In July 2023, the European Commission introduced Commission Delegated Regulation 2023/2197, establishing specific rules for assigning Unique Device Identifiers (UDI) to contact lenses. This regulation not only outlined tailored requirements for UDI-DI assignment but also provided manufacturers with an extended timeline to comply. Commission Delegated Regulation 2025/788 has now updated these provisions. While the original ...
AIB 2025-1/MDCG 2025-6: Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)
The MDCG has released a guidance document concerning the interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA). This document offers an initial set of answers to the most frequently asked questions concerning the joint application of the Artificial Intelligence Act (AIA) and ...
UPDATE: MDCG 2019-11 Rev.1 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
There has been an update to the guidance document MDCG 2019-11 concerning Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. originally released in 2019, this guidance document, aimed primarily at Medical Device Software (MDSW) manufacturers, offers guidance on the following: The criteria outlined in this document ...
EMDN Helpdesk is Now Active
The European Medical Device Nomenclature (EMDN) Helpdesk is now operational and ready to assist with your questions related to EMDN codes. This service, part of the SMEMDN project co-funded by the European Commission, is designed to help users navigate the EMDN structure—including categories, groups, and types—and to support manufacturers in selecting the correct EMDN code(s) ...
EU Commission Release New MIR Template
The European Commission has released an updated version of the Manufacturer Incident Report (MIR) form (Version 7.3.1), which was previously last revised in 2019. This form serves as a standardized template that manufacturers can use to report incidents involving medical devices to the relevant competent authorities. The New MIR form becomes mandatory as from November ...
Importance of Clinical Evaluations
In the evolving landscape of medical device regulation, clinical evaluation has taken centre stage. With the introduction of the Medical Device Regulation (EU) 2017/745 (MDR), the requirements around clinical evaluations have been significantly reinforced compared to the old Medical Device Directive (MDD). Understanding and meeting these requirements is not just a legal necessity; it is ...
