The New European Medical Devices Regulation
The Person Responsible for Regulating Compliance, New Obligations for Suppliers and Distributors – Part 2
This is Part 2 of the article on the New European Medical Devices Regulation published in Life Sciences Recht 2/2018.41
IV. Person responsible for regulatory compliance
A. Responsibilities
There is a completely new function that has been created along with article 15 of the MDR: “Manufacturers shall have available within their organization at least one person responsible for regulatory compliance who possesses…
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