Countdown to compliance – what the upcoming QMSR means for medical device development

What is the QMSR?

QMSR stands for Quality Management System Regulation. This is the new FDA regulation which amends the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.

Why has the QMSR been introduced?

With the QS regulation having remained largely unchanged since 1996, the QMSR allows for close alignment with ISO 13485. This global harmonisation streamlines quality system requirements, reduces the burden on regulated industries and “provides patients more efficient access to necessary devices.”

The FDA state that the introduction of the QMSR continues the FDA’s efforts to align its regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality medical devices for patients.

The move to bring the US and ISO 13485 requirements closer together is a great step toward streamlining the two divergent sets of QMS requirements.

The FDA are also using the new regulation as an opportunity to integrate risk management throughout the whole quality management system, not solely within the context of design validation. Not only is this more closely aligned with ISO 13485, but the expectation is that this will result in safer devices for the user.

The biggest changes between the QS regulation and QMSR

The QMSR places much more emphasis on risk-based decision-making, which is aligned to the approach in ISO 13485 and may be a new concept to those with previous experience of the FDA’s QS regulation only.

The specific amendments in the QMSR are made to: document controls, labelling and packaging control, records and servicing.

Control of records (Sec 820.35)

The QMSR has made changes regarding the control of records, to enforce that manufacturers must meet the requirements in accordance with ISO 13485 Clause 4.2.5 as well as further requirements from the FDA.

Handling complaints shall be dealt with in accordance with ISO 13585 Clause 8.2. Notably, if a complaint cannot be investigated due to lack of information, the manufacturer is required to document this and provide evidence that efforts have been made to gain the information. In addition, the situation whereby a complaint investigation must be initiated and records that must be retained pertaining to this, have been updated.

It is also now required that the Unique Device Identifier (UDI) is documented for each medical device, or batch of.

Device labelling and packaging controls (Sec 820.45)

Manufacturers must inspect their labelling and packaging for accuracy, documenting in accordance with ISO 13486 Clause 4.2.5. It specifically highlights that this inspection must be documented and occur “before use to assure that all devices have the correct labelling and packaging”. This addresses a trend identified by the FDA, whereby automatic readers have not been able to identify these types of errors. Having a designated individual examine, at minimum, a representative sample of those checked by an automatic reader, should address this issue.

Management audit exceptions (Sec 820.180(c))

Management reviews, quality audits and supplier audits were previously excluded from inspections. By following the example of ISO 13485 and removing this exception, it could be argued that the impact of the QMSR is minimal – content which makes up management review (e.g. NCRs, audit findings) were already in scope of inspection.

Are ISO 13485 and QMSR interchangeable?

Whilst the new QMSR incorporates (by reference) the QMS requirements of ISO 13485, the two standards are not interchangeable. Having an ISO 13485 certified QMS will set manufacturers in good stead for meeting QMSR requirements, however it does not mean that the FDA will not assess QMSR requirements. Likewise, there is currently no expectation that meeting QMSR requirements will replace the need to have an ISO 13485 compliant/certified QMS in other geographies.

When should manufacturers prepare for QMSR implementation?

The final rule for this amendment was issued by the FDA on the 31st of January, 2024 and the new QMSR comes into effect two years after this on the 2nd of February, 2026 and manufacturers should prepare to meet the requirements as soon as possible.

Interestingly, the original proposal from the FDA was for a one-year transition from the QS regulation to QMSR, however following industry feedback this was extended to two years.

The FDA have also communicated that they are developing a new inspection process to align with the requirements of the QMSR. This process is intended to be implemented from the QMSR effective date (2nd of February, 2026).

What is the impact of the QMSR?

For those companies that already have an ISO 13485:2016 certified QMS it is anticipated that the impact will be low. There will be some terminology updates expected, and the need to ensure that the few QMSR specific requirements are included in their processes and procedures.

For those companies that do not currently operate a QMS that meets the requirements of ISO 13485 it is to be expected that the impact of the implementation of the QMSR will be significantly higher.

The QMSR also reinforces, and increases, emphasis on a risk-based approach within a company QMS. This greater emphasis will require not only procedure / process updates but also a change in thinking with the company, to embrace risk assessment, and risk based decision making, as standard.

Will medical device manufacturers see any benefits?

A harmonised approach should lead to streamlined regulatory processes and so reduce burden on manufacturers (by removing the need to comply to multiple sets of requirements).

We believe that the QMSR also shows an increased focus on quality and safety of medical devices, which in turn means better patient outcomes (and increased trust).

Next steps

It is vital that companies conduct a thorough review, gap analysis and subsequent update of their QMS to ensure that the new QMSR requirements are adequately addressed. A plan to address these identified gaps will be critical to ensure that this is complete for the QMSR February 2026 effective date.

Link to resources

Federal Register :: Medical Devices; Quality System Regulation Amendments
Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions | FDA