The EC REP must be indicated on a product’s packaging. He or she represents the medical device manufacturer in its dealings with the authorities and bears third-party liability for the use of the products. Part of this duty includes appointing a safety officer. Diapharm takes on this responsibility on manufacturers’ behalf.
“Our services as an EC REP can also go beyond the regulatory requirements,” Diapharm General Manager Ralf Sibbing adds. “Diapharm’s years of experience and certified quality management systems enable it to take on a very wide range of responsibilities, from acting as an EC REP to playing the legal role of manufacturer.” As a result, non-European medical device manufacturers can choose whether they want to outsource full manufacturer responsibility for their products to the pharmaceutical service provider or allow Diapharm to represent them in their dealings with the European authorities.
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* Re-certification scheduled for July 2019