Saturday, June 15, 2024

EMA Updates Guidance on Drug-Device Combinations, Clarifying MDR/IVDR Requirements

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Drug-device combinations are the focus of the European Medicines Agency’s (EMA) recent update to its guidance for developers, providing crucial clarifications on several key issues. This update addresses six new questions and revises answer to 15 existing ones, aiming to help industry stakeholders and notified bodies better navigate the Medical Devices and In Vitro Diagnostic Regulations (MDR/IVDR).

The updated guidance offers detailed insights into how companies can seek advice on the classification of drug-device combinations and the consultation process for companion diagnostics. These clarifications are essential for ensuring compliance with the complex requirements imposed by MDR and IVDR, which differ significantly based on the type of product involved. For instance, devices with integral drug products, such as pre-filled syringes and transdermal patches, have different regulatory requirements compared to drug-eluting stents and other devices containing ancillary medicinal substances. Companion diagnostics, which are critical for the safe and effective use of specific medicinal products, also have distinct rules under these regulations.

One of the new questions added to the EMA’s guidance focuses on how companies can obtain advice about the classification of drug-device combinations, especially those that fall on the borderline between MDR and pharmaceutical legislation. The EMA’s Innovative Task Force can provide scientific views to aid development, but formal classification advice can only be given by national competent authorities. Another new question addresses the consultation procedure for companion diagnostics. The EMA has clarified when a notified body must seek the agency’s scientific opinion on the suitability of a companion diagnostic for a medicinal product. The guidance links to additional documents for more comprehensive information on companion diagnostics.

Clarified Regulatory Pathways and Revised Guidance for Drug-Device Combinations

These updates are significant for several reasons. Firstly, they provide clearer pathways for obtaining necessary regulatory advice, which is crucial for the development and authorization of innovative medical products. The clarification of consultation procedures ensures that companion diagnostics are appropriately matched with their corresponding medicinal products, enhancing patient safety and treatment efficacy.

Secondly, the revisions to existing questions reflect ongoing adjustments to the regulatory framework. For example, the response to a question about drug-device combinations authorized under the old directive now includes a paragraph that emphasizes the need to justify whether a change has a significant impact on a product’s safety or performance. This ensures that legacy products continue to meet current safety and efficacy standards.

The EMA’s updated guidance underscores the evolving nature of regulatory requirements and the agency’s commitment to supporting the industry through these changes. By providing detailed, up-to-date information, the EMA helps ensure that developers and notified bodies can effectively implement MDR and IVDR requirements. MDR and IVDR have imposed new obligations on companies seeking to obtain authorization for drug-device combinations. These regulations also affect notified bodies responsible for assessing the conformity of medical devices. The exact requirements vary depending on the type of product, making it essential for companies to stay informed about the latest regulatory expectations.

Drug-Device Combinations

EMA Enhances Guidance on Drug-Device Combinations, Addressing Emerging Issues and Regulatory Insights

The original question and answer document, published by the EMA in 2019, has been a valuable resource for stakeholders adapting to MDR and IVDR. The recent revisions enhance this resource by addressing emerging issues and incorporating the latest regulatory insights. The EMA’s updated guidance on drug-device combinations under MDR and IVDR provides critical clarifications that will help ensure compliance and facilitate the development of safe, effective medical products. By addressing new questions and refining existing answers, the EMA demonstrates its ongoing commitment to supporting the industry through regulatory transitions.

These updates are particularly important for developers working with complex products that straddle the line between medical devices and pharmaceuticals. The detailed guidance on classification, consultation procedures, and changes to authorized products will help these developers navigate the regulatory landscape more effectively.

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As the industry continues to innovate and develop new medical products, the EMA’s updated guidance will play a crucial role in ensuring that these products meet the highest standards of safety, quality, and efficacy. The agency’s proactive approach to addressing regulatory challenges and providing clear, actionable advice is essential for fostering innovation and protecting public health.


Resource: European Medicines Agency, May 21, 2024

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