Quality Management System Regulation (QMSR)

The QMSR replaced the Quality System Regulation on February 2, 2026. Manufacturers document a quality management system that meets ISO 13485 together with the FDA additions in Part 820, such as required content in complaint and servicing records, UDI, and links to Medical Device Reporting and to corrections and removals. Where ISO 13485 conflicts with the FD&C Act or FDA regulations, the FDA requirements prevail.

(a) Applicability. Current good manufacturing practice (CGMP) requirements are set forth in this quality management system regulation (QMSR). The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to assure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act and that the use of other terminology, such as “safety and performance,” in this part does not change this statutory standard or the requirements of this part. Any manufacturers engaged in the design, manufacture, packaging, labeling, storage, installation, or servicing of a finished device must establish and maintain a quality management system that is appropriate for its specific device(s). Manufacturers subject to this part include, but are not limited to, manufacturers that perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, as well as initial distributors of foreign entities that perform these functions. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.

21 CFR, 820.1(a)

A manufacturer subject to this part as described by § 820.1(a) must: (a) Document. Document a quality management system that complies with the applicable requirements of ISO 13485 (incorporated by reference, see § 820.7) and other applicable requirements of this part; and

21 CFR, 820.10(a)

The EU MDR does not incorporate ISO 13485 into the law. Article 10(9) lists what the quality management system must cover, and the harmonised EN ISO 13485 gives a presumption of conformity. In practice one ISO 13485 system can serve both markets, with the additions each one requires.