(June 19, 2015)
Following the public availability of the compromise Council position on the new medical device regulation, discussed and approved at the 19 June 2015 EPSCO meeting - unless further changes are made during the trialogue process - Authorized Representatives (AR's) who are independent from the supply chain now face significantly increased insurance bills and the prospect of having to charge their clients much higher fees for their services under the new Medical Device Regulation (MDR/IVDR), that is if they decide to stay in the AR business.
Given this important change the right choice of EC Authorized Representative (AR) will matter more than ever! The AR needs to be competent, do their due diligence and hold product liability insurance, which also covers negligence.
At this moment there's is a shakeout in notified bodies (NB's) - expect is to see the same in European AR's - with those remaining having better processes and offering more added value. But this will come at a cost - expect AR's to charge higher fees and be more risk averse.
If you already have an AR, but would like to maximize the services you receive, then engage MRM; we provide a smooth and transparent transition. Our transition procedure is seamless and simple. Please contact Dit e-mailadres wordt beveiligd tegen spambots. JavaScript dient ingeschakeld te zijn om het te bekijken. for a quotation.
