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What is Regulatory Compliance for medical devices containing integral ancillary medicinal substances?
Medical devices may contain substances which, if used separately, can be considered to be medicinal products, and have an ancillary function to the principal action of the device. These products fall under the Medical Device Regulation (Regulation 2017/745) and in addition to the evaluation of the medical device part by a Notified Body, a scientific opinion on the quality and safety of the ancillary medicinal substance, including the benefit or risk of its incorporation in the device, must be obtained from a national competent authority for medicinal products or from the EMA, before a notified body can issue a EU certificate (Article 1(8) and Annex IX section 5.2 of MDR).
Examples of medical devices containing integral ancillary medicinal substances include:
- Catheters with anti-microbial coating
- Drug coated stent
- Coated balloon catheters
- Bone cements containing antibiotic
- Condoms coated with spermicides
The consultation procedure may take more than 210 days (plus clock stops) to complete.
Manufacturers of medical devices containing integral ancillary medicinal substances are encouraged to develop a detailed regulatory strategy as early as possible in the development process for new products. An effective regulatory strategy can provide a detailed plan and schedule for regulatory approval that is consistent with the manufacturer’s plans for commercialization/ placing on the market.
Manufacturers should familiarize themselves with guidelines published by the regulators, authorities and competent third parties regarding the documentation required to support CE mark approval applications for medical device combination products. This can include the required content of 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 jeopardize product approval for medical device combination products.
How TÜV SÜD can assess your medical devices containing integral ancillary medicinal substances
TÜV SÜD Product Service has a global staff of medical device experts, with over 700 international specialists located in major markets around the world. This includes noted scientists, engineers, and physicians recognized as authorities in their respective fields.
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.
We have a long record of technical and regulatory expertise for medical devices certifications. We are a trusted partner for major markets according to international standards. We are a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.
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.
We have a long record of technical and regulatory expertise for medical devices certifications. We are a trusted partner for major markets according to international standards. We are a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.
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