Teams expanding a medical device internationally often treat EU MDR and MDSAP as interchangeable. They are not, they solve different problems, and you may need both.
EU MDR: market access in Europe
The EU Medical Device Regulation (2017/745) is the legal framework for placing a device on the European market. It governs CE marking, requiring conformity assessment, technical documentation, clinical evaluation, a unique device identifier, post-market surveillance, and (for most devices) review by a Notified Body. MDR is about whether and how you can sell in the EU.
MDSAP: one audit, several markets
The Medical Device Single Audit Program (MDSAP) is not a market-access regulation, it’s an audit program. A single MDSAP audit of your quality management system, conducted by an authorized auditing organization, is recognized by the regulatory authorities of five countries: the US, Canada, Brazil, Japan, and Australia. In Canada, MDSAP is mandatory; elsewhere it can satisfy or streamline QMS audit requirements. MDSAP is about auditing your QMS once instead of repeatedly for each market.
How they relate
- Both assume a mature ISO 13485 quality system underneath.
- MDR is the route to the EU market specifically (and the EU is not part of MDSAP).
- MDSAP reduces audit burden across the US, Canada, Brazil, Japan, and Australia.
A company selling broadly might pursue CE marking under MDR for Europe and maintain an MDSAP certificate to cover its QMS audits across the other major markets, all on one ISO 13485 foundation.
The practical takeaway
Map your target markets first, then decide what you actually need: MDR for Europe, MDSAP to consolidate QMS audits elsewhere, and ISO 13485 as the common base for both. Sequencing this well avoids duplicate work and surprise audit costs.
Sequence Group plans international market access, EU MDR technical documentation and MDSAP readiness, on a single ISO 13485 system. Get in touch.