Peru Class II Technical Report and Risk Management: The Eight Required Items

Regulatory information verified as of October 29, 2026

1. Key takeaways

The Class II dossier in Peru consists of the 7 items required for Class I plus item 8, the risk management report, for a total of 8 items. In addition, item 4, the technical report, must now include a list of the Essential Principles of Safety and Performance, the Principios Esenciales de Seguridad y Desempeño, as they relate to design and manufacture. The three layers of documentation must close into a single loop: every design measure stated in the technical report must be traceable to a corresponding risk in the risk management report, and must be pointed back to a specific entry in the Essential Principles list. When the three layers fail to reconcile, that mismatch is the most typical Class II nonconformity observed by reviewers. A Class II submission therefore succeeds or fails on cross-referencing discipline rather than on the volume of any single document.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: The Essential Principles list is an indexed presentation of evidence, not a letter of commitment.

The function of the Essential Principles is to decompose abstract safety and performance goals into decidable entries. The value of the list lies in giving, for every entry, a determination of applicable or not applicable together with the reason, and in pointing to the chapter or document number where the supporting evidence sits. For entries determined not applicable, a justification must be given, for example that the product contains no medicinal substance. A list that makes determinations without pointing anywhere cannot be verified by the reviewer and is treated as if no evidence had been presented at all. This is also the fundamental difference between the new framework introduced by D.S. N° 003-2020-SA and the legacy practice: templates written before 2017 under the condiciones esenciales wording are returned for redo in the new process because their wording system no longer matches.

Insight 2: The item 8 risk management report is the process record of conformity assessment, not a certificate of attainment.

A risk management report prepared under the current edition of ISO 14971 must display the complete chain of risk identification, risk evaluation, implementation of risk control measures, verification of the effectiveness of those measures, and the acceptability determination for residual risk. Every link in that chain must point to the location of its verification evidence. Mechanically, the reviewer tests whether each conclusion is supported by evidence: if any high-severity risk is judged acceptable in the report without a corresponding verification report or clinical or bench data behind it, the report is deemed incomplete. The report is therefore read as an argument whose every step must be checkable, not as a declaration that risks were considered.

Insight 3: Cross-layer consistency matters more than the thickness of any single document.

The design measures in the technical report, the risk controls in the risk management report, and the entries in the Essential Principles list must all reconcile with one another. The most common failure is not a missing layer but three layers written independently: the technical report describes a new construction feature, yet no corresponding hazard can be found in the risk management report; the Essential Principles list marks a principle as satisfied without indicating where in the technical report it is addressed. Such inconsistencies are very hard to correct within the 44 working days review clock through a single deficiency response, because corrections usually require synchronized version changes across multiple documents.

4. Practical recommendations

1. Maintain a three-layer cross-reference table linking Essential Principles entries, technical report chapters, and risk management report numbering, and run a bidirectional check before submission.
2. For every Essential Principles entry determined not applicable, state the reason and attach the supporting document; never leave the justification blank.
3. Use the current edition of ISO 14971 for the risk management report, state the edition number, and show it on the cover page.
4. Anchor every residual risk acceptability determination to a verification report number; conclusions without evidence sources are not accepted.
5. Projects still using pre-2017 legacy templates must complete the wording and structure migration to principios esenciales before submitting.
6. Schedule against the 44 working days review clock and prepare a version-change plan for the 30 working days deficiency correction window.

5. Verification checklist

□ All 8 items are complete, and item 8 is a risk management report under the current edition of ISO 14971

□ Item 4, the technical report, includes the Essential Principles list related to design and manufacture

□ Every list entry carries an applicable or not applicable determination with a pointer to a chapter or document number

□ Every not applicable entry states its reason

□ The three-layer cross-reference table has passed a bidirectional check

□ Every residual risk acceptability determination is anchored to a verification evidence number

□ The legacy condiciones esenciales wording has been fully replaced by principios esenciales

Regulatory information verified as of October 29, 2026.

*GRZAN Regulatory Team*

GRZAN provides medical device registration support in Peru for manufacturers, importers, and authorized representatives, covering Class II dossier assembly, Essential Principles mapping, risk management file review, and deficiency response. For inquiries, contact info@grzanglobal.com.