German medtech MDR to FDA bridge.
The corridor view. What carries from an MDR file into a US 510(k) submission, and what has to be rebuilt for FDA.
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The EU regulation governing medical devices placed on the European market, replacing the Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive.
Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, commonly referred to as MDR. Entered into force on 26 May 2017 with full date of application 26 May 2021, delayed by one year from the originally scheduled 2020 due to the COVID-19 pandemic. Replaces the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD). Transition periods for legacy CE-marked devices were extended by Regulation (EU) 2023/607, with end dates running through December 2027 for higher-risk classes and December 2028 for lower-risk classes.
MDR establishes a stricter framework than its predecessor directives. Core elements include enhanced clinical evidence requirements, mandatory Notified Body involvement for higher classes, with designated bodies including TUV SUD, TUV Rheinland, DEKRA, BSI, and DQS, Unique Device Identification (UDI), integration with the European database on medical devices (EUDAMED), the requirement for a Person Responsible for Regulatory Compliance (PRRC) under Article 15, and post-market surveillance with Post-Market Clinical Follow-up (PMCF). Article 32 requires a Summary of Safety and Clinical Performance (SSCP) for implantable devices and Class III devices, made publicly available through EUDAMED.
A CE mark issued under MDR is required for placing a medical device on the EU market. It does not, on its own, constitute clearance for the United States market. US market access requires a separate FDA pathway, typically a 510(k) Premarket Notification, De Novo classification, or a Premarket Approval (PMA), each evaluated against US-specific requirements distinct from MDR conformity assessment.
For European medtech firms moving from a CE mark under MDR to a US 510(k) submission, the regulatory bridge is structural. MDR clinical evaluation files, technical documentation under Annexes II and III, and Notified Body audit records are usable inputs to a US dossier, but they are not interchangeable with FDA expectations. Substantial equivalence to a US predicate, US biocompatibility requirements per ISO 10993 as recognised by FDA, software documentation under IEC 62304 in FDA-compatible form, and US labelling rules under 21 CFR Part 801 each require dedicated work. The detailed corridor view is in the German medtech MDR-to-FDA bridge pillar and the broader cross-border medtech commercialization pillar.
For US firms inbound to the EU, the inverse applies. A 510(k) clearance is not a substitute for MDR conformity assessment, and the EUDAMED registration, PRRC designation, and Authorised Representative requirements have no US analogue.
The corridor view. What carries from an MDR file into a US 510(k) submission, and what has to be rebuilt for FDA.
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