Posted by 
Eléonore Scaramozzino, Avocate, Constellation Avocats
The Medical Device Coordination Group (MDCG) has published MDCG 2021-24 Rev.1 (April 2026), updating its guidance on the classification of medical devices under MDR (EU) 2017/745. This revision provides further clarification and practical examples to support consistent application of classification rules across the EU. This guidance reflects the position of the Medical Device Coordination Group and is intended to support the stakeholders in the correct application of the regulatory framework.
How to use the rules ?
The manufacturer must take into consideration all the rules in order to establish the proper classification for its device. The strictest rule and sub-rule resulting in the highest classification determines the class25. It is quite conceivable for instance that one of the general rules that is not specific to active devices nevertheless applies to such a device. The intended purpose and all the device characteristics must be taken into consideration. The characteristic or combination of characteristics in accordance with the intended purpose of the device that falls into the highest class determines the class for the device as a whole. In addition to the classification rules set out in Annex VIII of MDR, the manufacturers must also take account of any applicable legal acts and consider guidance documents which may support the classification of their device.
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States, and it is chaired by a representative of the European Commission. MDCG 2021-24 Rev.1
BTx : Breakthrough Medical Devices & Breakthrough IVDs
The European Medicines Agency (EMA) is set to launch a pilot programme in the second quarter of 2026 to implement guidance on breakthrough devices (BtX) published by the Medical Device Coordination Group in December 2025.
The Medical Device Coordination Group published guidance on breakthrough devices (BtX) in December 2025 to accelerate access to highly innovative medical devices and in vitro diagnostics (IVDs) while maintaining rigorous safety and performance standards. Under the framework, manufacturers of breakthrough devices can access enhanced regulatory support and priority scientific advice from the medical device expert panels that EMA administers.
To obtain breakthrough designation, manufacturers need to request an opinion from EMA’s expert panels.
Pilot programme to be launched to support breakthrough medical devices and in vitro diagnostics
In the second quarter of 2026, the European Medicines Agency will launch a pilot programme to support breakthrough medical devices and in vitro diagnostics. The aim is to test a pathway that accelerates patient access to highly innovative technologies, always maintaining the EU’s high standards for safety and performance. Through the pilot, manufacturers of designated breakthrough devices will be able to benefit from enhanced regulatory support and priority scientific advice from the medical device expert panels administered by European Medicines Agency.
Ahead of the launch of the pilot in Q2 2026, the European Medicines Agency will hold a an online information session on 24 April 2026. This information session will present the main elements of the Breakthrough Devices framework outlined and highlight practical considerations for stakeholders preparing to engage with the process.
The pilot will be a crucial element to shape a future possible framework for breakthrough medical devices, which the Commission has included in its proposal of December 2025 revising the Medical Devices Regulation and In Vitro Devices Regulation (new Article 52a of the MDR and new Article 48a of IVDR).
This initiative marks an important step in strengthening Europe’s innovation-friendly regulatory environment for medical technologies. To obtain breakthrough designation, manufacturers will need to request an opinion from EMA’s expert panels, with further guidance and templates for applicants to be published by EMA ahead of the pilot’s launch. The pilot also supports the Commission’s wider objective of promoting innovation in areas of major public health interest and ensuring continued confidence in the quality, safety and performance of advanced medical devices placed on the EU market.
This document provides guidance for manufacturers, expert panels and notified bodies on the
process and regulatory considerations relevant for qualifying, assessing and certifying
breakthrough medical devices and breakthrough IVDs. It describes some key roles of actors
in this context, including EMA expert panels and national competent authorities, and outlines
the supports and opportunities available to manufacturers of BtX. This guidance also provides
considerations on the clinical evaluation / performance evaluation of BtX, as well as the role
of non-clinical data and preclinical evaluation, and post-market clinical follow-up / performance
follow-up for these devices.
This guidance document may apply to medical devices and IVDs across all technologies and
risk classifications.
Custom-made devices, in-house devices, and products listed in MDR Annex XVI without an
intended medical purpose are outside the scope of this guidance.