The Difference between Approval Processes for Medicinal Products and Medical Devices in Europe

The approval of new ophthalmic medical devices and medicinal products is governed by separate processes in Europe with different requirements, classifications, and timelines involved. For pharmaceuticals, companies can go through a centralized European-level process working with the European Medicines Agency (EMA) or a decentralized procedure working with a member state competent authority to gain approval or via mutual recognition. For medical devices, companies must work with a European Union approved Notified Body as there is no equivalent to the EMA. With medicinal products, approval can be sought as a new medicinal product, generic, known substance, or as an advanced therapy. With medical devices, the classifications are based on the use and complexity of the device as well as the risk, beginning with class I (surgical instruments and some diagnostic devices), to class IIA, class IIB, and class III, which are the most invasive devices, such as pacemakers and breast implants. From May 2021, the European Union will fully implement the Medical Device Regulation, which enforces increased requirements before class IIa and above devices can be CE marked. This process for approving medical devices and pharmaceuticals in Europe is designed to ensure that new technology is thoroughly vetted before becoming commercially available.