MDCG provides guidance on qualifying breakthrough devices
The European Commission’s Medical Device Working Group (MDCG) has issued guidance on Tuesday outlining the criteria for a device to qualify as a breakthrough (BtX) device under the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR).The guidance establishes an official EU framework for breakthrough devices in accordance with both directives.
“In alignment with the MDR and IVDR, this guidance presents recommendations for facilitating a streamlined pathway for CE marking and market access of breakthrough devices, to allow for timely patient access without compromising the clinical evidence requirements for these devices. It describes the opportunities and benefits available to manufacturers of BtX with the aim of eliminating undue delays and supporting the safe innovation and availability on the market of BtX,” according to the guidance.
A medical device is classified as a breakthrough device when it shows a significant level of innovation in technology, clinical procedures, or its application in clinical practice. Furthermore, the device is expected to have a significant positive impact on patients and public health, particularly for individuals suffering from life-threatening or irreversibly debilitating diseases or conditions.
The guidance excludes custom-made devices, in-house devices, and products listed in MDR Annex XVI that do not have a medical purpose.
The guidance outlines the criteria for designating breakthrough status, focusing on aspects of preclinical, clinical, and performance evaluation. It also addresses post-market surveillance considerations and the Clinical/Performance Evaluation Report (CER/PER).
To be classified as a BtX, manufacturers must seek scientific advice from the expert panels established under MDR Article 106. The expert panels will provide an opinion on the BtX status within 60 days of the designation request.
Manufacturers of class III devices and class IIb active devices intended to administer or remove a medicinal product may request early scientific advice in accordance with Article 61(2) of Regulation (EU) 2017/745 (MDR).
Manufacturers of devices from other risk classes may also seek guidance from expert panels regarding their assessment criteria for conformity, particularly concerning the clinical data necessary for clinical evaluation.
The document also covers the Clinical Evaluation Consultation Procedure (CECP) and details the activities and responsibilities of notified bodies.
The consultation of an expert panel in relation to a BtX is independent of the clinical evaluation consultation procedure (CECP) required under MDR Article 54(1).
The guidance specifies that notified bodies should “prioritise BtX files during planning and resource allocation, in view of their potential to address unmet medical needs or offer clinically meaningful advantages over existing solutions.” Notified bodies should also engage in early and structured dialogue with manufacturers to clarify expectations regarding the generation of clinical evidence.
The document also discusses the role of national competent authorities (NCAs) with respect to breakthrough devices. Among their responsibilities, NCAs are responsible for assessing clinical investigations of medical devices and clinical performance studies of IVDs, and conduct market surveillance.
The guidance indicates that benefits of the breakthrough program include receiving early scientific advice from the European Medicines Agency (EMA), engaging in early dialogue with notified bodies, and achieving greater predictability for conformity assessment timelines and expectations.
Guidance
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