Every day, manufacturers face the challenge of interpreting regulatory requirements and adapting them to their company situation. In many cases, it is difficult to answer specific questions and results in discussions and disputes between manufacturers, notified bodies and public authorities.
Topics such as intended use, approval and registration in various target markets raise more questions. Medical technology thrives on its diversity, which is difficult to regulate uniformly by regulatory requirements, so that ambiguities arise in many places in the legislation.
Medicines and medical devices are subject to different legal frameworks in Europe. Your challenge as a manufacturer is the regulatory classification of your product. This requires a precise distinction at an early stage of development. As a result, the studies necessary to confirm marketability are quite different for these two product types. Even with combination products consisting of a drug and medical device component, it is necessary to clarify under which guideline the product is regulated. But how can you be sure that you have assigned your product to the right regulation?
How We Can Help
Use our experience in creating expert opinion reports for submission to authorities or notified bodies as a basis for discussion and decision-making on demarcation and classification issues for your product.
Our global team can also prepare expert opinions for you as an independent colleague who presents facts in a science-based manner and in line with the current regulatory environment. We want to contribute to the success of your projects and to optimize your communication with the authority.