EU Conformity Assessment for Medical Devices: Updates & Pilot Program

“The European Medicines Agency (EMA) has introduced updates to its guidance on the conformity assessment and regulatory responsibilities for medical devices in the European Union (EU). This latest version, released on August 2, 2024, includes a new section on expert panel support for orphan medical devices and a pilot program aimed at high-risk devices.

The EMA prioritizes high-risk applications, especially for SMEs, and offers scientific advice for class III and class IIb active devices used to administer or remove medicinal products. The newly launched pilot initiative seeks manufacturers of high-risk medical devices, encouraging them to apply for free guidance to support the development and approval of orphan medical devices. This effort aims to streamline the regulatory process and promote innovation in medical device development in the EU.”

Source:https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices##~https://www.ema.europa.eu/en/news-events/whats-new

Region: EU Harmonized (27 Markets)