EU Medical Devices Regulation (MDR 2017/745)
What is EU Medical Devices Regulation (MDR 2017/745)?
Regulation (EU) 2017/745 (the MDR) is the EU horizontal regime for medical devices and accessories, replacing the prior MDD (93/42/EEC) and AIMDD (90/385/EEC) framework. It applied from 26 May 2021. It comprises 26 controls organised across 7 domains, and applies in the European Union.
How EU Medical Devices Regulation (MDR 2017/745) maps to other frameworks
All 26 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 7 domains EU Medical Devices Regulation (MDR 2017/745) groups its controls into
Where EU Medical Devices Regulation (MDR 2017/745) overlaps with the standards you already hold
What EU Medical Devices Regulation (MDR 2017/745) means in your sector
What EU Medical Devices Regulation (MDR 2017/745) means for your job
Questions people ask about EU Medical Devices Regulation (MDR 2017/745)
What is EU Medical Devices Regulation?
How many controls does EU Medical Devices Regulation have?
Where does EU Medical Devices Regulation apply?
What frameworks does EU Medical Devices Regulation map to?
How do I get started with EU Medical Devices Regulation compliance?
Query EU Medical Devices Regulation (MDR 2017/745) programmatically
EU Medical Devices Regulation (MDR 2017/745), its 26 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
EU Medical Devices Regulation (MDR 2017/745) API reference and MCP config →What EU Medical Devices Regulation (MDR 2017/745) requires, control by control
Each page carries the requirement text for one EU Medical Devices Regulation (MDR 2017/745) control and what an assessor expects to see as evidence.
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