What Is the EMA — and Why Should Medical Device Companies Care?

For U.S. medical device companies pursuing global market access, understanding the European regulatory landscape is essential. The European Medicines Agency (EMA) is not a device regulator like the FDA, but its role in the EU device ecosystem is more significant than many sponsors realize, and it is expanding.

What Is the EMA?

The European Medicines Agency is a decentralized agency of the European Union responsible for the evaluation, supervision, and safety monitoring of medicines. It is headquartered in Amsterdam and primarily serves the pharmaceutical and biologic space — but its mandate intersects with medical devices in specific, well-defined ways that matter for device sponsors.

How Medical Devices Are Actually Regulated in the EU

This is a critical point of confusion for U.S. sponsors accustomed to a single FDA pathway: medical devices are regulated at the EU Member State level. The pathway to market is CE marking, not EMA approval.

Manufacturers can affix a CE (Conformité Européenne) mark to a medical device after it has passed a conformity assessment. EU Member States designate accredited notified bodies to conduct conformity assessments. The EMA is not the competent authority for that process — national competent authorities and notified bodies are.

The Breakthrough Device Pilot — Now Live

EMA launched a pilot program to support the development of breakthrough medical devices on 28 April 2026. This is an EMA-administered scientific advice function — not a marketing authorization pathway — operating through the expert panel system.

Breakthrough designation can be granted to highly innovative medical devices that demonstrate the potential to address unmet medical needs or that offer substantial advantages over existing technologies. The assessment considers, among other aspects, the degree of innovation and the potential to address unmet medical needs or provide significant clinical benefit compared with existing alternatives.

Phase one is open to class III (high risk) medical devices and class IIb active medical devices intended to administer or remove medicines from the body. Subsequent phases will be open to other device types, including in vitro diagnostics.

The pilot is a first step toward the formal implementation of a breakthrough device framework, which the European Commission included in its December 2025 proposal to revise the MDR and IVDR. Sponsors of innovative devices should monitor this closely — what is currently a pilot pathway is on track to become statutory.

What This Means for Device Sponsors

For most standalone medical device submissions, the EMA is not your primary counterpart — your notified body and the relevant national competent authority are. However, EMA engagement becomes directly relevant when your device:

• Contains or is used in combination with a medicinal product
• Is a companion diagnostic paired with a centrally authorized drug
• Falls into the high-risk category requiring expert panel consultation
• Is a potential orphan or breakthrough device under the new pilot

For sponsors running global clinical trials supporting both FDA and CE mark submissions, the EU MDR framework sets the evidentiary bar that your data package must meet in Europe.

The EU MDR Framework

The Medical Devices Regulation (EU) 2017/745 applies to manufacturers placing new medical devices on the market and has been in place since May 26, 2021, repealing the previous directives on medical devices and active implantable medical devices. It introduced new responsibilities for EMA and national competent authorities in the assessment of certain categories of medical devices, including the expert panel consultation requirements for high-risk devices.

BSC's Perspective

Understanding the precise boundaries of EMA’s authority — and where it intersects with your device program — is essential before designing your EU regulatory strategy. At BSC, we help clients design clinical trials and statistical analysis plans that meet the evidentiary requirements of both the FDA and the EU MDR framework, whether you are pursuing a 510(k), PMA, or CE mark submission.

Questions about designing your clinical program for global regulatory pathways? Contact BSC.