U.S. FDA / EU MDR notified bodies

Note: "U.S. FDA / EU MDR notified bodies" is not a single organization. It combines two distinct medical-device regulatory concepts from two jurisdictions, profiled together here.

EU MDR Notified Bodies are independent conformity assessment bodies designated by EU Member States under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). They independently assess whether medium- and high-risk medical devices meet EU requirements before market access — conducting conformity assessments, auditing manufacturers' quality management systems, reviewing technical documentation and clinical evaluations, performing product testing, issuing CE certificates, and overseeing post-market surveillance. They are third parties, independent of manufacturers and separate from the competent authority. Certification is valid for 5 years, with annual surveillance audits and at least one unannounced audit per cycle. These regulations came into full application in May 2021 (MDR) and May 2022 (IVDR), replacing the older Medical Device Directive.

U.S. FDA device regulation is centralized within the agency itself rather than delegated to third parties. The FDA's Center for Devices and Radiological Health (CDRH) regulates firms that manufacture, repackage, relabel, and/or import medical devices sold in the U.S. Devices are sorted by risk class: most Class I devices are exempt from 510(k); most Class II require Premarket Notification 510(k); and most Class III require Premarket Approval (PMA), the most stringent marketing application.

Both systems pursue device safety and performance through structurally different mechanisms. The phrase "FDA notified bodies" is a category mismatch — the FDA does not use notified bodies; that term is EU-specific. Manufacturers selling in both markets must comply with both regimes in parallel, making innovations that streamline dual-jurisdiction compliance directly relevant.