Medical Device Quality Agreement | Europe

This editable quality agreement helps a medical device manufacturer and distributor in Europe define their respective quality and regulatory responsibilities. A responsibility table makes each party's role explicit before the agreement is signed.

Building a set? Buy procedures from the same family together and save: 5–9 for 20% off, 10–19 for 35%, 20–39 for 50%, or 40+ for 60%. The discount is applied automatically in your cart, or use Build Your QMS to choose and price a set.

Supplied as one editable Microsoft Word document in a digital download.

Quality responsibilities and agreement scope

It addresses regulatory clearances and approvals, packaging and labeling, quality-management requirements, complaint handling, vigilance, corrections and removals, and changes to the agreement. Tailor the allocation of duties to the actual parties, products and markets.

The agreement addresses MDR (EU) 2017/745 and ISO 13485:2016.

U.S. agreement for a different relationship

If you need to allocate responsibilities between a medical device company and a supplier for U.S. distribution, see the separately sold U.S. Medical Device Quality Agreement. Choose and adapt the agreement that matches the actual parties and market.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Quality Agreements and Consulting Contracts for workflow guidance, a checklist and common mistakes.