Agreement PRRC – Manufacturer (EU MDR & IVDR)


This generic template is providing the minimum requirements to contract a PRRC consultant Service Provider that will help your small or mid-size company to respect the EU MDR and IVDR requirements related to the Person Responsible for Regulatory Compliance.

The final document should still be reviewed and approved prior to use. This can be done internally by a subject matter expert or by a lawyer.

SKU: AGR-005 Categories: ,

This agreement is used by a small or mid-size manufacturer to appoint a Person Responsible for Regulatory Compliance (PRRC).

If you are considered a big company, you should not use this agreement as you need to hire a PRRC person within your organization. Same for an authorized representative.

Table of Content TOC PRRC Agreement - Medical Device manufacturer AGR-005 Rev A - Easy Medical Device


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