Economic Operators Checklist

As part of the new MDR 2017/745 and IVDR 2017/746, “Economic Operators”, organisations involved in the importation and distribution of medical devices, are subject to new regulatory changes that affect their ability to conduct business within the European Economic Area (EU).

Although each economic operator is individually responsible for compliance with the new MDR requirements, operators must confirm that all previous operators in the distribution chain have also adhered to regulations.

Don’t make a mistake, don’t miss out on this.

Using this tool it is easy to evaluate your roles and responsibilities as Economic Operators, including; Manufacturer, Authorized Representative, Distributor and Importer.

It provides a clear overview of the requirements and which Economic Operators it applies to.

Save yourselves time and serious headaches by using a tool specifically for this purpose.

Benefits:

• Use the template for all your products

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• Countless hours have gone into the development and refinement of this template

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Format: Microsoft Excel (2010/2013/2016)

Language: English (others available on request)

Disclaimer: After purchase this product is not subject to reimbursement