EPSP Essential Principles: A Clause-by-Clause Reading of Third Schedule Appendix 1

1. Key takeaways

The EPSP are the substantive safety and performance baseline for every Malaysian registration. The Essential Principles of Safety and Performance are set out in Appendix 1 of the Third Schedule to MDR 2012, and section 4(a) of Act 737 requires the manufacturer to ensure that the device complies with the prescribed principles. This is a statutory duty on the manufacturer, not a box for the agent to tick, which is why the conformity argument is examined line by line rather than accepted as a general statement of safety.

The principles are organised into eleven groups, running from the physical and biological properties of the materials through to performance evaluation. In the CSDT they are answered as a mapping table: each principle receives an applicability decision with reasons, the evidence relied on, and a conclusion. Leaving an item blank is not neutral; an empty line reads as an unaddressed requirement, and items marked not applicable without a reason are treated the same way.

• Legal home: Appendix 1 of the Third Schedule to MDR 2012; duty imposed by section 4(a) of Act 737.
• Structure: eleven principle groups, from materials to performance evaluation.
• Method: clause-by-clause mapping of applicability, evidence and conclusion.
• Not applicable is an answer: it needs a written justification, not a blank cell.
• Standard evidence is reusable: IEC and ISO reports carry across, but must be mapped to principle items.
• Reviewer focus: principles 2, 4, 10 and 11 generate most deficiency requests.

2. Legal basis

The obligation has two limbs. Section 4(a) of Act 737 places the duty on the manufacturer to ensure compliance with the prescribed principles, and Appendix 1 of the Third Schedule to MDR 2012 defines what those principles are. Guidance document MDA/GD-02, on the Essential Principles of Safety and Performance of Medical Devices, explains how each principle is to be demonstrated. The eleven groups are set out below in the order in which they appear in the Schedule. The references were verified on 19 October 2026.

Conformity is demonstrated inside the CSDT rather than in a separate certificate. For each principle the file states whether it applies, gives the reason for that decision, identifies the evidence, and records the conclusion drawn. Evidence in practice takes four forms: test reports, the standards applied, risk management outputs, and clinical data. The mapping is cumulative, so a gap at principle 1 tends to reappear as an unsupported conclusion at principle 11.

3. Expert insights

Insight 1: the mapping table is where the argument is won or lost. A dossier can contain excellent test reports and still fail the conformity read, because the reviewer is not assessing the reports in isolation. The question is whether each principle has been addressed and whether the evidence offered actually answers it. A report sitting in an appendix with no line connecting it to a principle is invisible to that test, which is why the mapping table, not the test volume, determines the outcome.

Insight 2: IEC and ISO evidence carries across, but only after mapping. Reports against IEC 60601 series and ISO 10993 series standards are accepted and need not be repeated. What has to be added is the translation layer: the report demonstrates conformity with a standard, while the reviewer needs conformity with a principle. National and industry standard reports usually require a standards comparison statement showing that the report covers the corresponding aspect of the principle. Skipping that statement leaves the reviewer to infer the link, and inference is where deficiencies begin.

Insight 3: four principles absorb most of the review attention. Principle 2, on infection and microbial contamination, principle 4, on measuring accuracy, principle 10, on the sufficiency of labelling and IFU information, and principle 11, on clinical and performance evidence, are the areas where deficiency requests concentrate. Three of the four depend on information the manufacturer controls directly rather than on laboratory capacity, which suggests where preparation effort returns the most.

Insight 4: the table should live with the product, not with the submission. Treated as a one-off filing artefact, the mapping is rebuilt from scratch at every change and every renewal. Treated as a controlled document, it becomes the instrument for change assessment: a design change first passes through an EPSP impact analysis, and only then is the question asked whether it triggers a CN (see article 43). That sequence prevents the common situation in which a change is notified late because nobody checked which principle it touched.

4. Practical recommendations

• Use one table with fixed columns. Principle number, applicability, justification, evidence reference, conclusion — the same five columns for all eleven groups.
• Write justifications for every not-applicable entry. A reason such as no patient contact, or no measuring function, is sufficient; a blank is not.
• Attach a standards comparison note. Where a national or industry standard report is relied on, state which principle aspect it covers.
• Prioritise principles 2, 4, 10 and 11 in internal review. Give them a second reader before submission.
• Link the table to risk management. Risk control measures should appear as evidence at the principle they address, not in a separate narrative.
• Version the table with the technical file. Hold it under the same change control as the design documentation so that impact analysis starts from a current baseline.

The consistent result of this discipline is fewer questions rather than a shorter file. Reviewers do not object to length; they object to an unanswered line. A complete table with modest evidence reads as a controlled submission, while a thin table with impressive appendices reads as an uncontrolled one.

5. Verification checklist

• □ All eleven principle groups present in the mapping table
• □ Applicability decision recorded for each principle, with reasons for exclusions
• □ Evidence reference given for every applicable principle
• □ IEC 60601 and ISO 10993 reports mapped to the relevant principle items
• □ Standards comparison statement attached for national or industry standard reports
• □ Principles 2, 4, 10 and 11 given a second internal review
• □ Table held under the same change control as the technical file, with EPSP impact analysis before any CN decision

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Malaysia. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the MDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com