What is the role of the European Medicines Agency (EMA) regarding medical devices?

The European Medicines Agency (EMA) plays a crucial role in the regulation of medicinal products, which encompasses a subset of medical devices—particularly those that are combined with medicines or have medicinal properties. The EMA focuses on ensuring that these products are safe, effective, and of high quality for patients in the European Union.

In its role, the EMA evaluates data and provides scientific advice related to these combined products, which fall under the jurisdiction of both medicinal products and medical devices. This includes oversight during clinical trials and post-marketing surveillance, ensuring that products are continuously monitored for safety and efficacy after they hit the market.

While the EMA does not directly market medical devices, regulate all clinical trial protocols for medical devices, or provide federal approval for all devices in the EU (as this task typically falls under the Medical Device Regulation and is carried out by notified bodies), its involvement with combined products signifies a critical intersection between pharmaceuticals and medical technology. This oversight by the EMA ensures that innovations which blend these two fields meet the stringent safety and efficacy standards set forth by European health authorities.