Checklist & compliance matrix
The UK MDR 2002 does not specify a mandatory format for the Essential Requirements checklist, but UKABs and MHRA expect all technical files to include a systematic demonstration of conformity with all applicable Essential Requirements in Schedule 1 (or Schedule 1A for IVDs). The checklist structure described here is consistent with best practice and UKAB expectations.
What is the ER checklist?
The Essential Requirements checklist (also called a compliance matrix or traceability matrix) is a document within the technical file that:
- Lists every Essential Requirement in Schedule 1 (or Schedule 1A)
- States whether each requirement is applicable to the device (and if not, why not)
- Identifies the method of demonstration — which standard, test, or evidence shows conformity
- Provides a technical file cross-reference — exactly where in the technical file the evidence can be found
The checklist is reviewed by UKABs during conformity assessment and by MHRA during audits. A well-structured checklist significantly reduces assessment time and demonstrates regulatory competence.
Structure of the checklist
Recommended columns
| Column | Content |
|---|---|
| ER reference | Specific ER number and title (e.g., "ER 2 — Risk reduction") |
| Applicable? | Yes / No / Partially |
| Justification if N/A | Where not applicable, state the reason (e.g., "device has no measuring function") |
| Method of demonstration | Standard applied, test performed, or other evidence type |
| Document / section reference | Exact location in the technical file (e.g., "Section 5 — Risk Management File, ISO 14971 Report, Rev 3") |
| Status | Conformant / In progress / Gap identified |
Worked example framework — Class IIb active general device
Below is an illustrative framework for a Class IIb active non-implantable device (e.g., a patient monitoring system with therapeutic alarming).
| ER | Applicable? | Method | TF Reference |
|---|---|---|---|
| ER 1 — Safety in intended use | Yes | Risk management per ISO 14971; clinical evaluation report | TF-05; TF-08 |
| ER 2 — Risk reduction hierarchy | Yes | ISO 14971 risk management file; design FMEA | TF-05 |
| ER 3 — Performance as intended | Yes | Bench performance testing; clinical evaluation | TF-06; TF-08 |
| ER 4 — Long-term stability | Yes | Accelerated ageing study; shelf-life data | TF-06.3 |
| ER 5 — Transport and storage | Yes | Distribution simulation testing (ASTM D4169); packaging validation | TF-06.4 |
| ER 6 — Acceptable side effects | Yes | Clinical evaluation — benefit-risk assessment | TF-08 |
| ER 7 — Chemical/biological properties | Yes — body contact surfaces | ISO 10993-1 biological evaluation; biocompatibility report | TF-06.1 |
| ER 8 — Infection / contamination | Partial — device not sterile; cleaning validated | Cleaning and disinfection validation report; reprocessing IFU | TF-06.5 |
| ER 9 — Measuring function | Yes — displays physiological parameters | Accuracy validation; comparison against reference standard | TF-06.2 |
| ER 10 — Energy source (electrical safety) | Yes — mains powered active device | IEC 60601-1 test report; IEC 60601-1-2 EMC test report | TF-07.1; TF-07.2 |
| ER 11 — Radiation | Not applicable — no ionising or non-ionising radiation emission intended | N/A | — |
| ER 12 — Software | Yes — embedded software | IEC 62304 software lifecycle documentation; software validation | TF-09 |
| ER 13 — Self-test/NPT | Not applicable — professional use only | N/A | — |
| ER 14 — Active implantable connection | Not applicable — no implanted components | N/A | — |
| ER 15 — Human blood/plasma | Not applicable — no human blood/plasma derivatives | N/A | — |
| ER 16 — Animal tissue | Not applicable — no animal tissue components | N/A | — |
| ER 17 — Administers medicines | Not applicable — does not administer medicines | N/A | — |
| ER 18 — Labelling and IFU | Yes | Labelling per Schedule 1 ER 18; IFU reviewed against requirements | TF-04.1; TF-04.2 |
Worked example framework — General IVD (self-declaration)
| ER (Schedule 1A) | Applicable? | Method | TF Reference |
|---|---|---|---|
| ER 1 — Safety | Yes | Performance evaluation; risk management file | PEV-01; RM-01 |
| ER 2 — Risk management | Yes | ISO 14971 risk management file | RM-01 |
| ER 3 — Performance | Yes | Analytical performance studies (precision, accuracy, linearity) | PEV-02 |
| ER 4 — Stability | Yes | Reagent stability studies; closed-vial/open-vial stability | PEV-03 |
| ER 5 — Transport | Yes | Freeze-thaw stability; shipping validation | PEV-04 |
| ER 6 — Side effects | Yes | Clinical performance evaluation; false rate analysis | PEV-02 |
| Schedule 1A — Analytical performance | Yes | EP studies per CLSI protocols | PEV-02 |
| Schedule 1A — Clinical performance | Yes | Clinical study / literature review; diagnostic sensitivity/specificity | PEV-05 |
| Schedule 1A — Calibration traceability | Yes | ISO 17511 traceability chain documentation | CALIB-01 |
| Schedule 1A — IFU requirements | Yes | IFU reviewed against Schedule 1A checklist | LABEL-01 |
| Schedule 1A — Labelling | Yes | Label design file; regulatory review checklist | LABEL-02 |
Common pitfalls
1. Treating N/A as a get-out-of-jail card
Marking an ER as "not applicable" without justification is a red flag for UKABs. Every N/A must have a device-specific rationale. "Not applicable — device has no measuring function" is acceptable. "Not applicable" with no reason is not.
2. Generic evidence references
Citing "ISO 14971" without specifying the document reference in the technical file is insufficient. Reference the specific report, section, and revision: "Risk Management File v2.1, Section 4: Risk Control Measures."
3. Static checklists
The checklist must be kept current. If the technical file is updated (new test data, design changes, post-market surveillance trigger), the checklist must reflect the change. Outdated cross-references undermine the entire conformity demonstration.
4. Conflating UK MDR 2002 and EU MDR GSPR
EU MDR GSPR (Annex I) has different numbering and more sub-requirements than UK MDR 2002 Schedule 1. A checklist prepared for EU MDR GSPR is not automatically compliant with UK MDR 2002 Schedule 1 (though it will typically exceed it). Check the specific numbering of requirements against the correct legal text for the market.
5. Missing applicable standards
If a UK-designated standard addresses your device type but you are not applying it, you must explain in the checklist why your alternative approach provides at least equivalent conformity. Not applying a relevant designated standard without explanation is an automatic challenge point.
Maintaining the checklist through the device lifecycle
The ER checklist is part of the technical file and must be maintained as a living document. Triggers for checklist review:
- Design change — any change that affects a device characteristic addressed by an ER
- New post-market data — adverse events, complaints, or PMS findings that challenge any ER
- Standard update — when a UK-designated standard is revised, the conformity method may need updating
- UKAB surveillance audit — the UKAB will typically review the checklist at surveillance audits
- MHRA inspection — MHRA may review the technical file and checklist during market surveillance
Related pages
- Essential Requirements — overview
- General requirements — ER 1–6
- Design and construction — ER 7–17
- IVD Essential Requirements (Schedule 1A)
- Technical documentation overview
- UK-designated standards
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 1 | General device ERs |
| UK MDR 2002, Part III, Schedule 1A | IVD ERs |
| MHRA: Designated standards | Current list of UK-designated standards |
| ISO 14971:2019 | Risk management |
| IEC 60601-1 | Electrical safety |
| IEC 62304 | Software lifecycle |