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...

read more

How Does the GDSN Work?

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

read more

UDI Submission for China NMPA

Despite frequent and rapid changes in the regulation process, companies cannot ignore the value of bringing medical devices to the Chinese market.  It is a potential high-growth area for many global medical device manufacturers.  So, if you’re a medical device...

read more

EUDAMED and GUDID – What’s Changed?

The European Database for Medical Devices (EUDAMED) EU MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the...

read more

EU-MDR Date of Application – Postponed…

The European Parliament has formally voted and adopted the amendment of its Medical Device Regulation (MDR) date of application. The Parliament has tabled and supported the four technical amendments proposed last week by the European Council, without additional...

read more

GUDID and UDI – Are You Prepared?

The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every medical device with an identifier.  Unique Device Identification (UDI) is a system to mark and identify medical devices (via...

read more