harmonized standards – Eisner Safety Consultants

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

FDA & EU MDD / AIMDD / IVDD Updated Standards Lists

Recently the FDA (United States) has released its latest List of Recognized Consensus Standards & the EU (European Union) has released updated lists of Harmonized Standards for the MDD (Medical Device Directive), the AIMDD (Active Implantable Medical Device Directive), and