The European Commission recently sent out an update on the plan for implementation and roll-out of EUDAMED, as it stands today. Changes to the implementation timeline of different modules, and how they will affect the application of each aspect of MDR are outlined...
As a medical device manufacturer, you are required to submit product data to the GUDID in order 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...
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...
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...
The US Food and Drug Administration (FDA) has released new guidance regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices. Effective immediately, the FDA has postponed GUDID (Global UDI Database) compliance for...
