EU MDR Annex II: Technical Documentation Structure, Section by Section

Table of Contents

• Introduction
• EU MDR Annex II at a glance — the six sections
• Section 1 — Device description and specification
  • Section 1.1 — the ten sub-elements, (a) to (j)
  • Section 1.2 — previous and similar generations

• Section 2 — Information supplied by the manufacturer
• Section 3 — Design and manufacturing information
• Section 4 — General safety and performance requirements
• Section 5 — Benefit-risk analysis and risk management
• Section 6 — Product verification and validation
  • Section 6.1 — pre-clinical and clinical data
  • Section 6.2 — additional information required in specific cases

• Annex II as the table of contents for your technical file
• How MDR Annex II maps to IVDR Annex II
• The three most common structural mistakes
• Frequently asked questions
• Conclusions

Introduction

Annex II of Regulation (EU) 2017/745 defines the structure of the technical documentation every medical device manufacturer must compile. It is short — six sections over a handful of pages — but it is the skeleton against which a Notified Body reviewer works, and the order it sets is not arbitrary.

Most manufacturers do not fail Annex II on content. They fail it on structure: sections numbered differently from the Regulation, evidence filed where the reviewer does not expect to find it, sub-elements silently omitted because they were absorbed into a paragraph elsewhere. A completeness check finds those in an afternoon, and each one is a question that has to be answered before the substantive review begins.

This guide walks Annex II section by section, with the sub-elements of each set out individually. For the wider context — what technical documentation is, how it is reviewed, and how Annex III post-market documentation fits alongside it — see the EU MDR technical documentation guide.

EU MDR Annex II at a glance — the six sections

Annex II has six sections, not seven, and their order in the Regulation is the order a reviewer expects to find them in your file.

Two things this table settles. First, labelling and instructions for use are Section 2, near the front — not an afterthought at the end. Second, the clinical evaluation is not a section of its own: it sits inside Section 6.1(c), alongside the pre-clinical evidence. Files that promote it to a top-level section, and push labelling to the back, are the two most common departures from the Regulation's own order.

Section 1 — Device description and specification

Section 1 is the foundation of the entire file. Everything downstream — the classification, the applicable GSPRs, the scope of the clinical evaluation, the risk analysis boundaries — derives from what is written here. It has two parts.

Section 1.1 — the ten sub-elements, (a) to (j)

Notified Body reviewers check Section 1.1 against its exact sub-lettering. A compliant Section 1.1 addresses each of the following, in order.

Section 1.2 — previous and similar generations

Section 1.2 requires two distinct overviews, and they are frequently merged into one:

Previous generations of the device from the same manufacturer, where they exist. This is the manufacturer's own history — and the place where a reviewer will look for a pattern of design changes that should have triggered risk management updates.

Similar devices available on the Union or international markets. This is the state-of-the-art anchor, and it feeds directly into the clinical evaluation. A Section 1.2 that names no similar devices at all invites the question of how the state of the art was established.

Section 2 — Information supplied by the manufacturer

Section 2 requires a complete set of the labels — on the device and on every level of packaging, including transport packaging where specific handling conditions apply — and the instructions for use, in the languages accepted by every Member State where the device is to be made available.

Its position matters. Labelling and IFU sit at Section 2 in the Regulation, immediately after the device description, because they are the manufacturer's declaration of what the device is and how it is to be used. Technical files that place them last, after the verification evidence, are following a habit inherited from the MDD rather than the structure of the MDR.

Two practical consequences follow. Up to 24 language versions may be required for a device marketed across the EU, each under document control and each needing a revision path when the IFU changes. And every claim in the label or IFU must be traceable to evidence elsewhere in the file — a claim without evidence is a finding, and a claim that contradicts the clinical evaluation is a serious one.

Section 3 — Design and manufacturing information

Section 3 has three parts, and the third is the one most often forgotten.

3.1 — Design stages. Information sufficient to allow the design stages applied to the device to be understood. In practice this is a narrative of the design and development process, tied to the design controls of ISO 13485 and Article 10: inputs, outputs, reviews, verification and validation.

3.2 — Manufacturing information. Complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring applied, and the final product testing. The word "complete" carries weight: summaries that reference internal documents without including the data are a common source of questions.

3.3 — Sites. Identification of all sites where design and manufacturing activities are performed, including suppliers and subcontractors. This is a frequent gap for manufacturers using contract manufacturers or outsourced sterilisation, where the site list stops at the manufacturer's own premises.

Section 4 — General safety and performance requirements

Section 4 is where the technical documentation meets Annex I. It requires a demonstration of conformity with the general safety and performance requirements applicable to the device, including justification, validation and verification of the solutions adopted. The demonstration must include four elements.

Those four elements are the reason a GSPR checklist has the columns it has. The full requirement-by-requirement breakdown, covering all 23 requirements of Annex I, is in the GSPR checklist guide.

The cross-reference obligation in (d) is the most frequently underestimated part of Section 4. It is not enough to name the evidence — the file must tell the reviewer where in the documentation to find it.

Section 5 — Benefit-risk analysis and risk management

Section 5 has two parts, and they are separate deliverables rather than two names for the same document.

(a) The benefit-risk analysis referred to in Sections 1 and 8 of Annex I. This is the weighing exercise: the clinical benefits set against the residual risks, supported by clinical evidence rather than by estimate. The benefit-risk analysis guide covers the methodology.

(b) The solutions adopted and the results of the risk management referred to in Section 3 of Annex I — in practice, the ISO 14971 risk management file: the plan, the hazard analysis, the risk controls with their verification, and the risk management report.

The most common finding on Section 5 is a benefit-risk analysis that restates the risk file rather than weighing anything. If the document contains no comparison against clinical benefit and no conclusion about acceptability, it is a risk summary wearing the wrong title.

Section 6 — Product verification and validation

Section 6 is the largest section and holds all the evidence that the device performs as intended. It divides into general evidence and special cases.

Section 6.1 — pre-clinical and clinical data

(a) Test results — engineering, laboratory, simulated use and animal testing, plus evaluation of published literature applicable to the device or to similar devices, addressing pre-clinical safety and conformity with the specifications.

(b) Detailed test information — test design, complete protocols, methods of data analysis, data summaries and conclusions, covering in particular:

• Biocompatibility, including identification of all materials in direct or indirect contact with the patient or user
• Physical, chemical and microbiological characterisation
• Electrical safety and electromagnetic compatibility
• Software verification and validation, per IEC 62304, describing the development process and the validation of the software as used in the finished device
• Stability, including shelf life
• Performance and safety

Where no new testing has been undertaken, the file must contain a rationale for that decision. "Not applicable" is not a rationale.

(c) The clinical evaluation report, its updates, and the clinical evaluation plan referred to in Article 61(12) and Annex XIV Part A. This is where the clinical evaluation lives in the structure of Annex II — inside Section 6, not as a section of its own.

(d) The PMCF plan and PMCF evaluation report referred to in Annex XIV Part B, or a justification for why post-market clinical follow-up is not applicable. The justification route is available but narrow, and a generic justification is one of the more reliable ways to generate a major finding.

Section 6.2 — additional information required in specific cases

Section 6.2 lists the situations that trigger additional documentation. Each applies only in defined circumstances, but where one applies and is not addressed, the omission is structural rather than editorial.

Section 6.2 is a screening exercise, not a writing exercise. The efficient approach is to review all seven triggers at the start of the file and record the outcome for each — applicable with a pointer to the evidence, or not applicable with a one-line reason. A file that simply omits the ones that do not apply gives the reviewer nothing to confirm against.

Annex II as the table of contents for your technical file

The simplest and most defensible table of contents for an MDR technical file is Annex II itself, in its own order, with Annex III appended:

• 1. Device description and specification — 1.1 (a) to (j), 1.2 previous and similar generations
• 2. Information supplied by the manufacturer — labels, packaging, IFU, language coverage
• 3. Design and manufacturing information — 3.1 design stages, 3.2 manufacturing and validation, 3.3 sites and suppliers
• 4. General safety and performance requirements — the GSPR checklist and its cross-references
• 5. Benefit-risk analysis and risk management — 5(a) benefit-risk, 5(b) risk management file
• 6. Product verification and validation — 6.1 pre-clinical and clinical data, 6.2 special cases
• 7. Annex III — post-market surveillance documentation: PMS plan, PSUR or PMSR, PMCF

Some manufacturers use the IMDRF non-IVD Table of Contents instead, particularly where the same file supports submissions in several jurisdictions. That is a reasonable choice, and Notified Bodies are familiar with it — but it is a different structure, and a file built to it needs an explicit mapping table showing where each Annex II section has landed. Without that map, the reviewer performing the completeness check has to construct it themselves, which is exactly the friction the structure was meant to remove.

The one approach that reliably causes problems is a third, invented order that follows neither.

How MDR Annex II maps to IVDR Annex II

Manufacturers with both device and diagnostic portfolios usually want a single template. The skeleton does carry across: Regulation (EU) 2017/746 uses the same six-section architecture for its Annex II, in the same order.

The divergence is inside Section 6. Where the MDR asks for pre-clinical testing and a clinical evaluation, the IVDR asks for scientific validity, analytical performance and clinical performance — a different evidence architecture with different acceptance criteria. Section 1.1 is sub-lettered in both, but the letters do not carry the same content, so a cross-reference written for one regulation will not survive being copied into the other.

Reuse the template. Do not reuse the row content, and do not reuse the sub-letter references.

The three most common structural mistakes

1. Renumbering the sections. Files that treat labelling as Section 7 and clinical evaluation as a standalone section are following MDD habits. The content may all be present, but the reviewer's completeness check runs against the Regulation's numbering, and every mismatch is a query.

2. Absorbing sub-elements into prose. Section 1.1 has ten lettered requirements; a well-written narrative can cover eight of them and leave (e) and (g) implicit. Implicit is not addressed. The safest structure gives each sub-letter its own heading or its own row.

3. Leaving the cross-references out of Section 4. Requirement (d) asks for the precise identity of the controlled documents and their location within the technical documentation. Naming the document satisfies half of it.

Frequently asked questions

How many sections does EU MDR Annex II have?

Six. Section 1 device description and specification; Section 2 information supplied by the manufacturer, meaning labels and instructions for use; Section 3 design and manufacturing information; Section 4 general safety and performance requirements; Section 5 benefit-risk analysis and risk management; Section 6 product verification and validation. Annex III, covering post-market surveillance documentation, sits alongside Annex II rather than inside it.

What is MDR Annex II Section 1.1?

Section 1.1 is the device description and specification, and it has ten lettered sub-elements from (a) to (j): trade name and general description with intended purpose and users; Basic UDI-DI or equivalent identification; intended patient population, conditions, indications, contra-indications and warnings; principles of operation and mode of action; rationale for qualification as a device; risk class and classification justification under Annex VIII; explanation of novel features; accessories and combination products; configurations and variants; and key functional elements with pictorial representations.

Where does the clinical evaluation sit in Annex II?

In Section 6.1(c), together with the clinical evaluation plan and its updates, alongside the pre-clinical evidence in 6.1(a) and (b). It is not a top-level section of Annex II, although many technical files treat it as one.

Where do labelling and instructions for use sit in Annex II?

Section 2, immediately after the device description. Placing them at the end of the file is one of the most common structural departures from the Regulation.

Is the IMDRF Table of Contents acceptable to Notified Bodies?

Yes, and it is widely used, particularly for files supporting submissions in more than one jurisdiction. If you use it, include an explicit mapping table showing where each Annex II section sits within the IMDRF structure — otherwise the completeness check becomes an exercise in reconstruction.

Does Annex II apply to Class I devices?

Yes. Every device placed on the EU market requires technical documentation meeting Annex II and Annex III, regardless of class. For Class I devices that are not sterile, do not have a measuring function and are not reusable surgical instruments, no Notified Body reviews the file — but a competent authority can request it at any time during market surveillance.

Conclusions

Annex II is six sections long and it is the cheapest part of the technical documentation to get right. The content takes months to produce; the structure takes an afternoon to align, and misaligning it costs a review cycle.

Three points carry most of the value. Labelling and instructions for use belong at Section 2, not at the end. The clinical evaluation belongs inside Section 6.1(c), not as a section of its own. And Section 4 requires not only the identity of the evidence but a cross-reference to where it sits in the file.

For manufacturers building the file from scratch, the EU MDR technical documentation guide covers the wider review process and the Annex III post-market documentation, and the GSPR checklist covers Section 4 requirement by requirement.

Related articles

• EU MDR Technical Documentation Requirements
• EU MDR GSPR Checklist
• EU MDR Clinical Evaluation Report
• ISO 14971 Risk Management
• Benefit-Risk Analysis
• EU MDR Transition Deadlines