Saturday, June 22, 2024

New Guidance on Medical Device Regulations for Industry

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A new revision of the guidance for applicants, marketing authorization holders, and notified bodies of medical devices has been published by the European Medicines Agency (EMA). This comprehensive question-and-answer document aims to clarify the regulatory requirements for devices used in combination with medicines. By providing detailed practical considerations, it aids in the implementation of the medical devices and in vitro diagnostic regulations for these complex combinations. This guidance is crucial for stakeholders involved in the development, approval, and oversight of combination products, ensuring they navigate the regulatory landscape effectively.

The updated document addresses various aspects of the regulatory framework, reflecting the latest experiences and actual cases encountered since the implementation of the new regulations. It aims to provide clear and actionable guidance to help industry participants meet the stringent requirements set forth by the regulations. By doing so, it promotes a better understanding of the expectations for compliance and the processes involved in bringing combination products to market.

The guidance document serves as an essential resource for ensuring that the integration of medicinal products and medical devices meets high standards of safety, efficacy, and quality. It emphasizes the importance of regulatory alignment and the need for consistent application of the rules across different jurisdictions. This harmonization is vital for maintaining public trust in these products and for facilitating international cooperation in the medical device and pharmaceutical industries. This revision represents a significant step forward in the regulatory management of combination products, providing much-needed clarity and support to those involved in their development and oversight.

New Guidance Streamlines Regulations for Combination Medical Devices and Drugs

Products that combine a medicinal product and a medical device are regulated either under the pharmaceutical framework or the medical device framework, depending on their main mode of action. The updated guidance is based on experiences since the implementation of the new regulations and actual cases encountered. The document offers regulatory and procedural guidance for integral drug-device combinations, co-packaged medicinal products, consultation procedures for devices with an ancillary medicinal substance, and companion diagnostics.

Integral drug-device combinations are medical devices that form an integral product with a medicine, such as pre-filled syringes. The guidance covers their lifecycle management, ensuring that these products meet the necessary regulatory requirements throughout their use. This includes aspects such as labeling, packaging, and regulatory submissions to ensure patient safety and efficacy.

Medicinal products that include a medical device in their packaging, referred to as co-packaged, must adhere to specific labeling requirements. The guidance provides detailed instructions on how these products should be labeled to ensure clear communication of their usage and regulatory compliance. Proper labeling is crucial for patient safety and effective use of the combination products.

Medical Device

Updated Regulations and Guidance for Safe and Effective Combination of Medical Devices

The guidance also outlines the consultation procedure for medical devices with an ancillary medicinal substance. This procedure ensures that substances supporting the proper functioning of the device are adequately assessed for safety and efficacy. Additionally, the guidance covers the consultation procedure for companion diagnostics, which are diagnostic tests essential for the correct use of a specific medicine. These procedures are vital for ensuring that combination products meet high standards of safety and effectiveness.

The guidance is provided to support the application of the regulations on medical devices (Regulation (EU) 2017/745) and on in vitro diagnostic devices (Regulation (EU) 2017/746). These two regulations have changed the European legal structure for medical devices, introducing new responsibilities and requirements for the European Medicines Agency and national competent authorities. This includes the assessment of certain categories of medical devices used in combination with medicines.

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These updates are essential for maintaining the integrity and safety of combination products in the medical field. By following the revised guidance, companies can ensure they meet the necessary regulatory standards, thereby safeguarding patient health and ensuring the effective use of combination products. The document reflects a collaborative effort to address the complexities of regulating products that straddle both pharmaceutical and medical device frameworks.


Resource: European Medicines Agency, May 21, 2024

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