The medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives (MDD) or Medical Device Regulation (MDR) by affexing CE marking logo on the product packaging. The CE mark is a legal requirement to place a device on the market in the EU terotory.
As a Regulatory Consultant and Authorized European Representative for MDD and MDR, EuropeCert has the technical expertise, experience and qualified manpower to provide complete solutions for CE marking services.
EUROPECERT is a turnkey (full scope) service provider from Germany to comply Medical Device regulation for Europe and America. This means whatever type or Risk class of device you manufacturer and wishes to market in Europe or America, EUROPCER has the technical expertise to provide appropriate technical Guidance and related services.
New Medical Devices Regulation is released by European commision
It is important that you prepare the Medical Device Technical File to meet the new requirements by end of 2019, so you are ready for MDR certification soon after your Notified Body is identified.
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