The European Commission’s Medical Device Coordination Group (MDCG) has issued new guidance clarifying how medical devices and in vitro diagnostics can qualify as breakthrough devices under the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). The guidance establishes a formal EU-level framework intended to support innovative technologies while maintaining robust clinical and performance evidence requirements.
This marks an important step for manufacturers developing novel devices designed to address unmet medical needs, particularly for serious or life-threatening conditions.
What Qualifies as a Breakthrough Device in the EU
Under the guidance, a device may qualify as a breakthrough if it demonstrates a high level of innovation in technology, clinical methodology, or application in clinical practice. In addition to innovation, the device must be expected to provide a meaningful benefit to patients or public health, especially for conditions that are irreversibly debilitating or life-threatening.
The guidance applies across both MDR and IVDR frameworks but excludes custom-made devices, in-house devices, and products listed in MDR Annex XVI that do not have a medical purpose.
Purpose of the Breakthrough Framework
The MDCG guidance is designed to facilitate a more streamlined pathway to CE marking and market access for qualifying devices without lowering regulatory standards. The goal is to reduce unnecessary delays in conformity assessment while preserving rigorous requirements for safety, performance, and clinical evidence.
Rather than accelerating approvals outright, the framework emphasizes earlier regulatory engagement, clearer expectations, and improved coordination among EU regulatory stakeholders.
Evidence Expectations and Regulatory Pathways
To support breakthrough designation, manufacturers must demonstrate strong preclinical, clinical, and performance evidence showing that the device offers a significant improvement over existing solutions or addresses an unmet need. Robust Clinical Evaluation Reports or Performance Evaluation Reports and comprehensive post-market surveillance planning remain essential.
Manufacturers seeking breakthrough status are required to request scientific advice from expert panels established under MDR Article 106. These panels are expected to provide an opinion on breakthrough designation within 60 days of a request.
For certain higher-risk devices, including class III devices and class IIb active devices involved in medicinal product administration or removal, early scientific advice may also be requested under MDR Article 61. Manufacturers of other risk classes may engage expert panels to clarify clinical evidence and conformity assessment expectations.
Role of Notified Bodies and Competent Authorities
The guidance encourages notified bodies to prioritize breakthrough device submissions and engage in early, structured dialogue with manufacturers to align on clinical evidence generation and review timelines. Consultation with expert panels for breakthrough designation remains separate from the Clinical Evaluation Consultation Procedure required under MDR.
National competent authorities retain responsibility for clinical investigation oversight, performance study assessments, and post-market surveillance activities.
How EMMA International Supports Breakthrough Device Developers
At EMMA International, we support medical device and IVD manufacturers navigating MDR and IVDR compliance, including breakthrough device strategy, clinical evidence planning, expert panel engagement, and notified body coordination. Our team helps clients align innovation with regulatory expectations to support efficient market access.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
