MDCG guidance
MDR/IVDR Language requirements: Overview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific country
MDCG guidance · Other guidance documents · January 2024
Key facts
| Reference | MDR/IVDR Language requirements |
|---|---|
| Title | Overview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific country |
| Topic | Other guidance documents |
| Published | January 2024 |
| Document | health.ec.europa.eu |
At a glance
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- MDR/IVDR Language requirements (January 2024) Revisions on file
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About MDCG guidance documents
The Medical Device Coordination Group (MDCG), made up of EU member-state experts, endorses guidance on applying the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Each page here covers one document and all of its revisions.