EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
What is EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?
Regulation (EU) 2017/746 (the IVDR) is the EU horizontal regime for in vitro diagnostic medical devices (IVDs). It applied from 26 May 2022 and replaced Directive 98/79/EC. It comprises 26 controls organised across 7 domains, and applies in the European Union.
How EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 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 In Vitro Diagnostic Medical Devices Regulation (IVDR) groups its controls into
Frameworks that share controls with EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
Each of these has at least one control mapped to a control in EU In Vitro Diagnostic Medical Devices Regulation (IVDR). The number is how many EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls are shared, counted from the mapping graph.
Implementation guides for frameworks that overlap EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
Where EU In Vitro Diagnostic Medical Devices Regulation (IVDR) overlaps with the standards you already hold
Where to get trained on EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
One course in the catalogue covers EU In Vitro Diagnostic Medical Devices Regulation (IVDR) directly. Each is self-paced, includes the downloadable toolkit and the implementation playbook, and carries a certificate of completion.
What EU In Vitro Diagnostic Medical Devices Regulation (IVDR) means in your sector
What EU In Vitro Diagnostic Medical Devices Regulation (IVDR) means for your job
Questions people ask about EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
What is EU In Vitro Diagnostic Medical Devices Regulation?
How many controls does EU In Vitro Diagnostic Medical Devices Regulation have?
Where does EU In Vitro Diagnostic Medical Devices Regulation apply?
What frameworks does EU In Vitro Diagnostic Medical Devices Regulation map to?
How do I get started with EU In Vitro Diagnostic Medical Devices Regulation compliance?
Query EU In Vitro Diagnostic Medical Devices Regulation (IVDR) programmatically
EU In Vitro Diagnostic Medical Devices Regulation (IVDR), 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 In Vitro Diagnostic Medical Devices Regulation (IVDR) API reference and MCP config →What EU In Vitro Diagnostic Medical Devices Regulation (IVDR) requires, control by control
Each page carries the requirement text for one EU In Vitro Diagnostic Medical Devices Regulation (IVDR) control and what an assessor expects to see as evidence.
- IVDR-ART-10 General obligations of manufacturers (Article 10)
- IVDR-ART-110 Transitional provisions (Article 110 as amended by (EU) 2024/1860)
- IVDR-ART-15 Person Responsible for Regulatory Compliance (Article 15)
- IVDR-ART-4 Genetic information, counselling and informed consent for genetic tests (Article 4)
- IVDR-ART-78 Post-market surveillance plan and system (Article 78)
How ready are you for EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?
Answer 25 questions and get a professional readiness report with gap analysis, maturity scores, and prioritised action items. Results in 5 minutes.