MDCG guidance
European Medicines Agency (EMA) Guidance: Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)
MDCG guidance · Other guidance documents · June 2021
Key facts
| Reference | European Medicines Agency (EMA) Guidance |
|---|---|
| Title | Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) |
| Topic | Other guidance documents |
| Published | June 2021 |
| Document | ema.europa.eu |
At a glance
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- European Medicines Agency (EMA) Guidance (June 2021) 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.