Approval of Drug/Device Combination Products

ACHIEVING REGULATORY COMPLIANCE FOR DRUG/DEVICE PRODUCTS

Many of today’s most innovative medical devices are actually drug-device combination products that generally include a medical device part and a drug part. Combination products are often medical devices that have been coated or impregnated with a drug substance, such as a catheter with an anti microbial coating, or a drug coated stent. Other examples of combination products include coated balloon catheters and bone cements containing antibiotic and condoms coated with spermicides.

REGULATORY LANDSCAPE FOR DRUG/DEVICE PRODUCTS

Despite the clinical advantages offered by combination products in treating certain medical conditions, the regulatory review and approval process for combination products is generally more complex than that applicable to non-combination products. In the European Union (EU), for example, the evaluation by a Notified Body of medical devices incorporating medicinal substances must include an opinion of a competent authority designated by an EU Member State or the EMA, a process that can take more than 210 days (210 days + clocks stops) to complete. Manufacturers of combination products are encouraged to develop a detailed regulatory strategy as early as possible in the development process for new combination products. An effective regulatory strategy can provide a detailed plan and schedule for the regulatory approval process that is consistent with the manufacturer’s plans for market introduction. Combination product manufacturers should also seek advice from regulators, authorities and competent third-parties regarding the documentation required to support CE mark approval applications, including clinical evaluation reports, drug file (CTD-Format) and technical documentation. These steps serve to make the approval process as efficient as possible, and can help reduce the risk of unexpected challenges and setbacks that can prolong or jeopardise product approval.

WHY CHOOSE TÜV SÜD

TÜV SÜD Product Service has a global staff of medical device experts, with over 700 international specialists located in major markets around the world. These specialists are supported by TÜV SÜD Product Service’s own Clinical Centre of Excellence, and a scientific advisory board comprised of scientists and physicians from the leading universities and healthcare centres.

OUR SERVICES AT A GLANCE

• Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
• Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971.

YOUR BENEFITS AT A GLANCE

• Recognised medical device expertise - TÜV SÜD Product Service is one of the largest EU Notified Body in the world. Our global network of more than 750 dedicated medical health and services professionals include noted scientists, engineers, and physicians recognised as authorities in their respective fields.
• Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
• Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms