EU MDR versus New Zealand Classification: Why Conclusions Do Not Transfer

Regulatory information verified as of 29 October 2026

1. Key takeaways

On its page Risk Classification of Medical Devices (Revised: 10 May 2011), Medsafe states: “Recent or planned changes to risk classification systems in Europe and Australia mean there are now differences between risk classifications in those regulatory regimes and New Zealand.” The meaning is direct: EU and Australian classification conclusions cannot be transplanted to New Zealand.

The New Zealand system sits in regulations 11 to 13 and Schedule 2 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325): 22 rules, 5 risk classes and 2 subclasses, determined by exclusion backwards from rule 22. Medsafe explains on the same page that the rules were made “Following the principles of the Global Harmonisation Task Force (GHTF)” — GHTF principles, not the European system. In vitro diagnostic devices are not on this path; their classification code is IVD.

The duty falls on the Sponsor (New Zealand sponsor); Medsafe states expressly that “The Regulations require a sponsor to determine the correct risk classification of its medical devices”. Misalignment makes the correct-classification statement in the reg 7 declaration inaccurate, affecting in turn the reg 5(2) identifier and reg 5(3) grouping.

2. Legal basis

The table below lists the sources verified and the provisions relied on.

3. Expert insights

Insight 1: three points of purchase in the Medsafe statement.

Recent or planned changes shows the differences are not static — Europe and Australia keep changing while New Zealand’s rules rest in the 2003 regulations. Differences and New Zealand is a formal official acknowledgement, removing the legal basis for direct application. The same page offers only one path: return to the 22 Schedule 2 rules and exclude rule by rule. Since the difference is officially stated, relying on foreign conclusions loses the defence of not knowing.

Insight 2: the systemic root of the misalignment.

Since SR 2003/325 came into force on 1 January 2004, its classification duty provisions (regs 5–10, 14) have not been substantively amended; the three amendments in the current version (as at 7 August 2020) are formal: reg 14 by s 413 of the Criminal Procedure Act 2011 on 1 July 2013; the reg 3 device definition by s 50 of the Medicines Amendment Act 2013 on 1 July 2014; and reg 3 by s 135 of the Public Service Act 2020 on 7 August 2020. The rule text stood still while other jurisdictions rebuilt; the two regimes diverged. Affected provisions can only be confirmed clause by clause; the categories below are the ones GRZAN repeatedly finds misaligned (practical estimate).

Insight 3: the product categories most easily misaligned.

First, IVDs. Medsafe recognises no IVD risk classification model and uniformly uses the code IVD; the EU IVDR’s four-level grading has no entry point in New Zealand — the largest misalignment of all. The 22 rules of Schedule 2 and the reg 5(2) identifier do not apply to devices using the IVD classification (practical estimate). Medsafe further notes that voluntarily notified IVDs need not enter animal-derived material information or formulations.

Second, devices incorporating medicines. Schedule 2 rule 14 covers them: a device incorporating, as an integral constituent part, a substance that constitutes a medicinal product on its own and may have an ancillary action on the patient’s body is placed in Class III by rule 14(2). Schedule 1(a) separately exempts devices that also constitute a medicinal product, but excludes devices to which rule 13(2) applies — active devices administering or removing a medicinal product from the patient’s body in a potentially hazardous manner. Rule 14 and rule 13(2) target different objects; mixing them up inevitably misclassifies.

Third, devices with animal-derived, microbial or recombinant-derived materials: a dedicated clause points to Class III, with wording not fully matching the European rules.

Fourth, software. New Zealand has only reg 13(5) — software shares the classification of the device it drives or influences; Medsafe has no dedicated SaMD guidance, and stand-alone software’s characterisation is a practical estimate. Applying the European software grading rules directly will fail.

Fifth, Class I subclasses. New Zealand uses basic, measuring and sterile; the Medsafe page lists reusable surgical instruments as Class I basic, and the European counterpart subclass has no entry point here.

Sixth, products with dedicated clauses: rule 15 (contraception and STD prevention), rule 16 (contact lens and device disinfecting or cleaning products), rule 17 (non-active diagnostic X-ray imaging recorders), rule 19 (blood bags) and rule 22 (breast implants, Class III) each carry independent clauses and thresholds, to be checked clause by clause rather than filled from foreign conclusions.

Insight 4: the cost chain of misalignment.

The conclusion is written into WAND and forms the first item of the reg 7 declaration. Misalignment means an inaccurate declaration, triggering the reg 8 10 working day correction duty and the reg 14 fine not exceeding NZ$500 on conviction; a class set too low manages a high-risk device through a low-risk channel, weakening the safety evidence position under s 38 of the Medicines Act 1981.

4. Practical recommendations

• GRZAN requires every product entering New Zealand to undergo a fresh local determination; the determination table must set out parallel columns of the European, Australian and New Zealand conclusions with reasons for differences stated; direct reliance on foreign conclusions is not accepted.
• GRZAN recommends listing IVDs, devices incorporating medicines or biological-source materials, software, and products under the topic-specific clauses of Schedule 2 rules 14 to 19 and 21 to 22 as mandatory re-verification categories, whatever the foreign conclusion says.
• Follow the Medsafe official order strictly: work backwards from rule 22 to rule 2; anything not excluded is Class I; the conclusion must derive from site of contact, mode of action and duration. IVDs are not on this path — no IVD risk model is recognised, the code IVD is used uniformly, and the 22 rules and the reg 5(2) identifier do not apply to devices using it (practical estimate).
• Apply the 7 principles of reg 13, emphasising (3) separate classification for combination devices, (4) accessories separately, (5) software shares its device’s class, and (7) take the highest.
• The classification conclusion must be confirmed in writing by the manufacturer and the determination table retained; foreign conclusions are attached as reference only, never as the basis of determination.
• As soon as the class changes, correct WAND within 10 working days under reg 8, and re-check simultaneously whether the unique product identifier obligation and grouping eligibility have changed.

5. Verification checklist

• □ The current Medsafe Risk Classification page text has been obtained, its differences statement confirmed.
• □ The backwards scan of Schedule 2 from rule 22 to rule 2 has been completed.
• □ The European, Australian and New Zealand columns are completed side by side, differences explained.
• □ IVDs uniformly use the IVD classification code, without foreign letter grades.
• □ Devices incorporating medicines or biological-source materials, software, and products under Schedule 2 rules 14 to 19 and 21 to 22 are on the mandatory re-verification list.
• □ The three escalation factors (site of contact, mode of action, duration) are documented item by item.
• □ The classification conclusion is confirmed in writing by the manufacturer.
• □ The reg 8 correction mechanism on classification change, with reg 5(2) and reg 5(3) re-checks, is established.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the New Zealand market. Our team prepares WAND-compliant evidence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com