GUDID Data Submission Services: 3 Potential Risks

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...

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...

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...