As soon as your product is intended for more than one market you need to think global and consider every changing regulations and normative requirements
Defining the destination markets for a combination product is challenging. Due to development times of several years, the regulatory environment and quality and customer’s expectations may change significantly by the time the product is submitted for regulatory approval or by the time it reaches the market. Using transition times before major changes can be a suitable strategy, however, the combination of all regulations that apply, have to be kept in mind. In our own experience, it is advisable to document the regulatory strategy and product description before significant investments are done, and then make risk-based decisions that include the possibility of unexpected changes in the regulatory environment. In many cases we have treated combination products as if they were developed for the US market under the “combination product gold standard regulation” 21 CFR part 4, even if they are not. In Europe, we have crossed the midpoint of the transition period for the new MDR, which is affecting combination products, and attempts to squeeze timelines to benefit from “pre-MDR” submissions become increasingly risky.
And finally, development projects need to consider all destination markets in terms of supply chain logistics, such as the choice of the manufacturing sites, local regulations for release of product, and of course for regulatory clearance.
- 21 CFR part 4
- Combination Product
- Global regulations
- Medical Device Regulation (MDR)
- Supply chain
- The challenges we encounter (and address) regularly, in many cases have to do with requirements not fully defined, or the target markets have not been decided on due to limited visibility.
- Also, in the area of injection systems, the market is quickly developing in the direction of increased complexity with the advent of new technologies such as on-body-injectors (OBIs) or the use of connectivity.
- The regulatory requirements for devices used in combination products are generally depending on the intended use (the drug product intended to be delivered), however, regulatory treatment of the device itself is undergoing significant changes.
- Sharing our experience and recommendations (consulting) based on global reach and experience
- Generating technical documentation under the customers Quality Management System or under ours (ISO 13485 certification may or may not be required)
- Support with the definition of a development strategy suitable for all intended markets
- Gap analysis in case a bridging from one market to another is desired
- Compliant development support for all intended submissions