Document:EU MDCG Guidelines -: Difference between revisions
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|reference=EU MDCG Guidelines - | |reference=EU MDCG Guidelines - | ||
|validity_area=EU | |validity_area=EU | ||
Latest revision as of 12:54, 16 July 2026
| Document information | |
|---|---|
| Reference | EU MDCG Guidelines - |
| Validity area | EU |
| Scope(s) | MD |
| Document name | MDCG Guidelines |
| Version / Revision | - |
| Status | N.A. |
| Document type | Corpus of texts |
| Language(s) | EN |
| Description | EMA – Medical Device Coordination Group (MDCG)
Guidance - MDCG endorsed documents and other guidance: - Annex XVI products (Regulation EU 2017/745) - Borderline and Classification - Class I Devices - Clinical investigation and evaluation - COVID-19 - Custom-Made Devices - European database on medical devices (EUDAMED) - European Medical Device Nomenclature (EMDN) - Implant cards - In-house devices - Authorised Representatives, Importers, Distributors - In Vitro Diagnostic medical devices (IVD) - New technologies - Notified bodies - Person responsible for regulatory compliance (PRRC) - Post-Market Surveillance and Vigilance (PMSV) - Standards - Unique Device Identifier (UDI) - Other topics - Other guidance documents |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
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