4 December, 2020

White paper: Economic Operators, are you prepared?

Along with the MDR, more stringent requirements are introduced for Economic operators involved in the distribution of medical devices to the European market. On December 1, 2020 the actor registration module of EUDAMED has been made available. In this white paper, the first in a series of papers co-authored by Clarvin, Devicia, Kickfile and Morris Law, an overview of the requirements for each of the different actors defined as Economic Operators will be provided. The most significant changes for Economic Operators when transitioning from the Medical Device Directive (MDD) to the MDR are highlighted.

One of the most significant changes for Economic Operators is the extended focus on compliance across the supply chain of medical devices. All parties involved in the manufacturing and distribution of medical devices to and/or within the European Union (EU) need to identify their role(s) in the supply chain and comply with their obligations and responsibilities under the MDR.

Changes to the responsibilities of Economic Operators include:
Manufacturer: while still bearing the utmost liability for its products, this liability is now shared with the other Economic Operators.
Authorised representative: the Authorised Representative will take on more risk and liability.
Distributor: Several new obligations are introduced under the MDR that Distributors have not been accustomed to previously. In fact, certain measures taken by the Distributor may result in the Distributor assuming the obligations incumbent on Manufacturers.
Importer: The introduction of a new role in confirming the compliance of devices and must now meet specific requirements and verify information from the Manufacturer. 

Read the white paper to learn more: Do you need help with regulatory compliance? Clarvin, Devicia, Kickfile, and Morris Law – a group of Life Science experts – offer full service for all your medical device compliance needs. We can advise you on clinical and regulatory strategies for your medical device, and can support you with everything from agreements, clinical investigation strategy and design, implementation of Quality Management Systems, and in establishing Technical Documentation for your device. Please see our contact information on the last page.

This white paper is the first in a series of white papers published by 
Morris LawClarvinKickfile and Devicia