PMCF Planning as per EU MDR

As the Medical Device Regulation (MDR) deadlines are approaching for re-certification and/or introduction of new products, manufacturers are also working to start or fulfil the Post-market Clinical Follow-up (PMCF) activities as per requirements set out in Annex XIV, part B of the MDR. The Annex states “PMCF shall be understood to be a continuous process…

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.