Medical Device Quality Agreement | Europe

The Medical Device Quality Agreement for Europe includes required agreement content and defined responsibilities between a manufacturer and a distributor of medical devices per the legal requirements specified in Medical Device Regulation, MDR (EU) 2017/745 and ISO 13485:2016.

• MDR 2017/745 aligned

• ISO 13485:2016 aligned

• MS Word Format

• Digital Content - Instant Download

The Medical Device Quality Agreement for Europe includes required agreement content and defined responsibilities between a manufacturer and a distributor of medical devices. The quality agreement can be easily modified, as needed, to adapt to a wide range of circumstances and user needs.

Quality Agreement for EU Overview

The Medical Device Quality Agreement for EU defines the responsibilities of the "Company" and "Distributor" for the following subject matter: The Quality Agreement includes detailed table of responsibilities to clearly define both parties responsibilities to ensure a proper "meeting of the minds" and clarity as to each parties role for each defined topic.

• Regulatory Clearances and Approvals

• Packaging and Labeling

• Quality Management System Requirements

• Complaint Handling

• Vigilance

• Corrections and Removals

• Amendments to Agreement

• and more

Quality Agreement for EU Compliance

The Medical Device Quality Agreement for EU supports implementation of the European Medical Device Regulation MDR (EU) 2017/745.

For more information about our Medical Device Quality Agreement for Europe contact us at [email protected]