Medical Writing EU Regulations Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR

Volume 29, Issue 3 - EU Regulations

Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR

Abstract

The new European Database on Medical Devices (Eudamed) is the platform to be used for the prospective registration of clinical investigations for medical devices under the Medical Device Regulations. However, Eudamed’s launch has been delayed till 2022. This article discusses the ramifications and the potential solutions for manufacturers to comply with public disclosure expectations and requirements. Until Eudamed is available, posting on other databases is recommended so manufacturers can meet requirements for clinical investigation transparency and disclosure while sharing clinical investigation information necessary to maintain public trust.

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Editorial
President's Message
EMWA News
The In Vitro Diagnosgtics Regulation and the role of medicals writers
Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR
Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers
New documents required by the medical device regulation
Risk management plans in the EU: Managing safety concerns
Scientific advice procedures in the EU – an overview ofthe regulatory background
EU software regulations: The new normal or innovation stagnation?
The new PubMed – underestimated regulatory obstacles
Ethical challenges in acknowledging professional writing support
Publication management software for medical writers
Regulatory Matters
News from the EMA
Medical Devices
Medical Communications and Writing for Patients
Getting Your Foot in the Door
Lingua Franca and Beyond
My First Medical Writing
In the Bookstores
Good Writing Practice

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