EUDAMED UPDATE: Actor Registration Module

European Commission just announced the availability of the EUDAMED Actor Registration module for voluntary, production use by Member States and Economic Operators. The EUDAMED database is a key enabling feature (central database and collaboration tool) of the new...

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M2M Testing – What it means and why it’s important.

Medical Device Regulation (MDR) is a set of recent European regulations aimed to enhance patient safety and modernise public health.  Published in May 2017 by the European Commission (EU COM), they are an overhaul and expansion of the MDD (Medical Device Directives)...

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EUDAMED: Playground Testing Update

EUDAMED go-live date is still scheduled for May 2022. In order to ensure a smooth and effective implementation, the EU COM is providing a “EUDAMED playground” available for both manual web‑based user access and an automated M2M (machine‑to‑machine) Data Exchange for...

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How Does the GDSN Work?

Globally, the medical device manufacturing sector continues to grow steadily due to ageing populations in developed economies, growing health concerns and the acceleration of digital health. But like any industry, growth requires the ability to seize opportunities...

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GUDID Data Submission Services: Potential Risks

As a medical device manufacturer, you are required to submit product data to the GUDID in order to meet UDI compliance requirements. If your company markets relatively few products in America, you may simply choose to do so by uploading spreadsheets directly to the...

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