Using the RS-01 recognised standards list: editions, supersession and evidence chains

1. Key takeaways

Document RS-01, List of Recognised Standards for Medical Devices, is the MDD publication that records which standards are recognised, and its function is to turn conformity with the Essential Principles into executable technical standards. Using it requires answering three questions. Which edition applies, since whether the list identifies an edition or only a standard number is a matter of what the published document says. Whether an old test report survives a standard revision, which depends on whether the superseded edition remains in the list. And whether the evidence chain is closed, because standard, test report and Essential Principles clause must be mutually traceable.

The list is therefore not a catalogue to browse but a mapping instrument. Its value depends on the precision with which each entry is tied to a clause and to a test report.

• Recognition is a shortcut, not the only route. A listed standard allows the reviewer to accept inferred conformity; an unlisted standard requires the applicant to argue the mapping.
• Edition control is a continuing obligation. A standard that leaves the list weakens the reports that relied on it.
• Software standards move faster. TR-007 was updated on 1 September 2025, and software citation needs re-checking alongside it.
• Closure beats volume. Twenty standards with no clause mapping are worth less than five with a clear mapping.
• Reviewers check clause by clause. The review is organised around the Essential Principles, not around the standards list.

2. Legal basis

RS-01 is published by MDD as the recognised standards list and operates alongside TR-004, which contains the principles being satisfied, and TR-002, which governs the summary in which the standards and their evidence are cited. GN-02 sets the technical documentation requirements for general devices. TR-007, updated with a Chinese version issued on 1 September 2025, carries the software and cybersecurity requirements that determine which standards are relevant to software-containing devices.

The relationship between the documents is directional. TR-004 states the obligation, RS-01 identifies a standard whose use is recognised as satisfying it, and TR-002 is where the applicant records the connection. A file that cites standards without that chain in place has the appearance of technical rigour without its substance.

3. Expert insights

Recognised standards are a shortcut to the Essential Principles, not the only path. Where a standard on the list is applied, the reviewer can accept the inferred conformity directly. Where a standard outside the list is applied, the applicant must argue how that standard covers the relevant principle. The first saves time; the second consumes argument. Neither is prohibited, but the cost difference is real and should be a deliberate choice rather than an accident of which edition the laboratory happened to use.

Edition change is a continuing obligation, not a one-off task. When a standard is revised and the superseded edition is removed from the list, the supporting force of a test report written against the old edition declines accordingly. Manufacturers should maintain a standard edition register for every listed product and re-check it item by item whenever RS-01 is updated. Without that register, the discovery that a report is out of date arrives with a customer question rather than with a planning decision.

The standing of software and cybersecurity standards has risen. TR-007 was updated on 1 September 2025, so standard citations for software-containing devices need to be reviewed at the same time. Software standards are typically revised on a shorter cycle than hardware standards, a practical estimate drawn from observation rather than from a published rule, and that shorter cycle means the register has to be refreshed more often for these products than for mechanical ones.

A closed evidence chain matters more than the number of standards. Listing twenty standards without being able to point to a specific Essential Principles clause is weaker than listing five with a clear correspondence for each. The reviewer works through the Essential Principles clause by clause, not through the standards list, so the file should be organised in the order the review is conducted.

The mapping table is the deliverable. What the reviewer needs is a table in which each principle names the standard applied, the test report that demonstrates it and the location of that report. Once that table exists, the summary and the checklist can both be written from it, and the three documents stay consistent by construction.

4. Practical recommendations

• Work backwards from the Essential Principles. Start from TR-004 and find, clause by clause, the corresponding recognised standard in RS-01, building a mapping table as the output.
• Keep a standard edition register. Record for each standard the edition adopted, its publication date, the date of the test report and the period for which the report remains valid.
• Run a gap analysis after each revision. When a standard is revised, analyse the differences between editions first and decide whether retesting is needed, rather than retesting everything as a default.
• Write a justification for unlisted standards. Where a standard outside the list is used, attach a one-page explanation of how it covers the relevant Essential Principles clause.
• Re-check software citations against TR-007. Treat the software standard set as a separate register with its own review rhythm.

5. Verification checklist

• □ The current version of RS-01 has been obtained and the standards used have been checked against it.
• □ A standard edition register has been established.
• □ The mapping from standard to test report to Essential Principles clause has been completed.
• □ A gap analysis has been completed for revised standards.
• □ Standards outside the list are supported by a written justification.
• □ Software-containing products have had their standard citations re-checked against TR-007.

Regulatory information verified as at 29 October 2026. The legislation, guidance and effective dates described in this article are limited to the content published by the official sources listed under legal basis on that date; where those sources are updated, the latest published version prevails.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Hong Kong, China. Our team prepares MDACS-compliant dossiers, coordinates evidence of reference approvals and ISO 13485 certificates, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com