Category: who | Last Updated: 13 days ago | Views: 83
The Responsible person must be designated by a written mandate, and has to accept this role in writing. The Responsible person can be the manufacturer (if established in the EU), a distributor, an importer, or a professional (designated) Responsible person.
The Responsible person, who must have a presence in the EU, guarantees compliance with the Regulation to European authorities, and ensures that the product is safe for human health under normal and reasonably foreseeable …
What is the EU PRRC? Thus, the role of Person Responsible for Regulatory Compliance (PRRC) was created. Article 15 of the European MDR and IVDR mandate the appointment of this person and this June 2019 EU PRRC guidance document provides more clarity on the requirements. Many people have asked us what this new role entails and who needs to comply.
Who is responsible for CE marking? The European CE marking directives, intend to make one person the main responsible and accountable for CE compliance. The way to identify that responsible person is rather unique for these directives. One would expect that the directives state that the ’manufacturer’ is responsible for CE marking. But instead they define two moments in time
How do I provide my Responsible Person(s) to Wish to ? To link a Responsible Person to a product, click the dropdown under the “EU Responsible Person” column in the row of the product. Select your applicable Responsible Person to link them to the product. You can also use the checkbox on the left to mark multiple products and link them all to a Responsible Person using the dropdown as seen below.Last modified: July 25 2021
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