EU Commission MDR & IVDR Standardization Request List – Will it Succeed?

EU Commission MDR & IVDR Standardization Request List – Will it Succeed?

COMMISSION IMPLEMENTATION DECISION M/575 was issued 14 April 2021: This is a list of standards the EU Commission is hoping to Harmonize under MDR and IVDR.  One of the issues is the HAS consultant has issued a negative assessment on

Standards & Regulatory Update – Medical Electrical Devices – Article

Standards & Regulatory Update – Medical Electrical Devices – Article

In the June issue of InCompliance Magazine I provide advice in an article on how to remain current on medical electrical device standards (including those in development) and regulatory guidance documents.  I start up at the International level (IEC & ISO)