European Medicines Agency (EMA)
The EMA is a decentralized agency of the EU. It is responsible for the scientific evaluation, supervision and safety monitoring of medical agents.
Therefore, consultation of the EMA is required in addition if a medical device contains:
- medicinal products
- human tissues and cells
- biocidal products or food products.
In some cases, consultation of other agencies such as the European Chemicals Agency or the European Food Safety Authority might be necessary.
