In the ever-evolving landscape of healthcare, the development of combination products that integrate both medical devices and drugs has become a prominent feature. These innovative solutions offer a multifaceted approach to addressing complex medical conditions, often providing enhanced efficacy and convenience. Within the European Union (EU), the regulation of combination medical device and drug products is meticulously governed by a comprehensive framework to ensure patient safety, efficacy, and regulatory compliance.
The regulatory pathway for combination products in the EU is outlined in a harmonized manner to address the unique challenges posed by these hybrid products. The European Medicines Agency (EMA) and the European Commission collaborate to establish and implement regulations that govern the development, approval, and post-market surveillance of combination products.
Much like in the US, combination products are classified based on their primary mode of action. If the primary intended action is that of a medicinal product, it falls under the jurisdiction of the EMA. Conversely, if the primary action is that of a medical device, it is regulated by the competent national authority.
The evaluation process for combination products involves close collaboration between the EMA and relevant national authorities. This joint approach ensures that both the medicinal and device components are thoroughly assessed, considering their individual and combined effects. Notified Bodies play a crucial role in assessing and certifying the conformity of medical devices. For combination products, these bodies collaborate with the EMA to ensure a comprehensive evaluation.
For products where the device and drug components are integral to each other, a single marketing authorization application may be submitted to streamline the evaluation process.
Medicinal products within combination products adhere to the regulatory framework set out in the EU pharmaceutical legislation, such as the centralized, decentralized, or mutual recognition procedures.
Medical devices follow the requirements outlined in the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR), depending on their classification.
While the EU regulatory framework for combination products is comprehensive, challenges persist. The need for clear guidelines, consistent interpretation, and adaptability to rapidly advancing technologies and scientific knowledge is an ongoing consideration. As the landscape of healthcare continues to evolve, regulators must remain agile to address emerging complexities.
Through a harmonized and collaborative framework, the EU works to ensure that combination products undergo rigorous evaluation and scrutiny, balancing the benefits of innovation with the criticality of safeguarding public health. As technology and medical science progress, the regulatory framework will undoubtedly evolve, reflecting a dynamic commitment to excellence in healthcare regulation. EMMA International can support bringing your combination product to market globally. Call us at 248-987-4497 or email info@emmainternational.com to learn more!
EMA (n.d.) Medicines used in combination with a medical device retrieved on 1/11/2024 from: https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices#:~:text=Medicinal%20products%20used%20in%20combination%20with%20a%20medical%20device,-Some%20medicines%20are&text=The%20entire%20product%20is%20regulated,authorisation%20for%20a%20medicinal%20product.&text=Examples%20include%3A,pre%2Dfilled%20syringes%20and%20pens
