The 2016 edition sets requirements for design, production, document control, traceability, risk management and post-market activities. Certification is voluntary under the standard itself, but the MDR requires manufacturers to have a quality management system, and in practice a certified ISO 13485 system is how most show they do. Since February 2, 2026, FDA's QMSR also builds on it.

Why it matters for labeling

Clause 4.2.4 requires document control: documents are reviewed and approved before issue, changes and current revision status are identified, relevant versions are available where they are used, and obsolete documents are prevented from unintended use. For labeling, that means being able to show which version was approved and which one was released. The standard also expects labeling and packaging operations to be controlled as part of production.

Common mistakes

  • Label files held outside the document control system
  • Obsolete labels still available for reprints
  • Approvals that identify a file name but not a version
  • Supplier labeling, such as printers' files, that the system doesn't cover

Sources