The management representative is not the PRRC

5.5.2 appoints someone to run the system, not clear a device

Clause 5.5.2 requires top management to appoint a member of its own management — irrespective of other responsibilities that person carries — with responsibility and authority covering three things: making sure the processes the quality management system needs are established, implemented, and maintained; reporting to top management on how the QMS is performing and where it needs improvement; and making sure awareness of applicable regulatory requirements and the QMS itself is promoted throughout the organization. Every part of that mandate is written at the level of the system as a whole. Nothing in Clause 5.5.2 asks this person to personally check any single device's conformity before it ships, or to sign anything device-specific at all.

Article 15 hands a named person device-facing duties

The PRRC's job runs the opposite direction. Article 15(3)'s four duties tie the role to specific devices and specific filings: checking device conformity before release, keeping technical documentation and the declaration of conformity current, meeting the vigilance reporting obligations in Articles 87 to 91, and issuing the investigational-device statement Annex XV requires. Article 15(4) then protects the person who does that job from retaliation for doing it — a clause built for the exact friction of someone refusing to clear a release the QMS hasn't actually earned. ISO 13485 itself, written as a standard multiple regulators reference rather than one jurisdiction's own text, has no equivalent: no named individual carrying personal, device-level release authority anywhere in its clauses.

QMSR carries the first role into the US; it doesn't create the second

Since QMSR's February 2, 2026 compliance date folded ISO 13485:2016 into 21 CFR 820 by reference, Clause 5.5.2's management representative travels into a US-regulated quality system the same way the rest of Clause 5 does. What doesn't travel with it is anything resembling Article 15. QMSR's own supplemental requirements, carried in Subparts A and B, don't add a named, personally accountable compliance officer with device-release duties — that construct is specific to the EU regime, not a feature of the harmonized standard FDA now cites. A manufacturer selling only into the US needs a management representative and nothing more. The day it also CE-marks a device under MDR or IVDR, Article 15 adds a second, EU-only role on top of the first — not a renamed version of it.

One person can hold both, if the record shows it

Neither text forbids one person from holding both roles, and at a manufacturer of ordinary size that's exactly what a QA/RA director often does. What breaks is a job description or org chart that collapses the two into a single line item, “compliance,” because the record each duty produces is different in kind. Management review minutes and internal-audit trend data are what prove Clause 5.5.2 was actually performed; device-specific release checks and technical documentation with a current revision history are what prove Article 15(3) was. A compliance file that can point to one but not the other has left half of a dual mandate unaddressed, whatever the org chart's single name suggests.

Where this meets the rest of the file

A dual-role description that keeps Clause 5.5.2's system-level mandate and Article 15's personal, device-facing duty list on separate lines — mapped to what each regulator actually reviews when it asks for evidence — is previewed in the launch catalog. If your organization combines or separates these roles differently, the shelf takes that correction directly.