EUDAMED – European Database for Medical Devices

EUDAMED is an upcoming part of the newly enforce European (EU) Regulations 2017/745. EUDAMED database will be a transparent system aiming at coordinating information regarding medical devices available in the EU market. EU Commission in co-ordination with MDCG is currently working on the database planning, creation, and implementation. The new MDR based requirements will be imposed once EUDAMED becomes fully function in the market.
Please find our blog discussing upcoming information on MDR EUDAMED.

Medical Device Industry and COVID-19: Regulatory Modifications to Consider

The COVID-19 pandemic has overwhelmed our healthcare delivery systems and has effected the delivery of medical care across the spectrum. Medical device companies have also been hit by the crisis
as they struggle to make decisions regarding supply chains, and regulatory obligations in the midst of uncertainty.
Please find our blog discussing the impact of the pandemic on medical device regulations.