MDR and IVDR Technical Documentation: Annex II and III Section by Section, with What Notified Bodies Check

The obligation is the same in both regulations, but the contents differ: MDR Annex II asks for clinical data, IVDR Annex II for analytical and clinical performance data and stability data. Both annexes are read below section by section with the Annex III plan and reports, followed by the classes whose file a notified body assesses device by device or by representative sample, retention and access, and the changes the pending Commission proposal of December 2025 would make.

What Technical Documentation Is

Technical documentation, often called the technical file, is the set of documents that MDR Annex II and Annex III, and the same-numbered annexes of the IVDR, require a manufacturer to draw up, keep up to date and present in a clear, organised, readily searchable and unambiguous manner. The presentation rule comes from the preamble of MDR Annex II.

Both regulations entered into force on 25 May 2017; the MDR has applied since 26 May 2021 and the IVDR since 26 May 2022, both directly applicable in every member state. MDR Annexes II and III and IVDR Annex II have not been amended since adoption. Read against the whole set of rules, the file is one obligation in the framework of the EU MDR and IVDR.

Who Draws It Up and Who Is Exempt

The manufacturer draws up the technical documentation: MDR Article 10(4) covers devices other than custom-made devices, and IVDR Article 10(4) covers IVDs. The duty sits with the manufacturer whatever the class of the device.

Class I devices under the MDR and class A IVDs need the same Annex II and III file, whether or not a notified body is involved: their manufacturer draws up the technical documentation and issues the EU declaration of conformity (MDR Article 52(7), IVDR Article 48(10)). That declaration is a separate duty under MDR Article 10(6) and IVDR Article 10(5). Custom-made devices are excluded from MDR Article 10(4) and follow MDR Annex XIII, as the last section explains.

Technical File, STED and the Summary on Request

The regulations use the term "technical documentation"; "technical file" is the common name, and STED (summary technical documentation) is a format from outside the MDR, while the structure the MDR sets is that of Annex II. A summary does appear in the regulations, but in another role: on request, a competent authority receives the technical documentation in its entirety or a summary of it (MDR Article 10(8), IVDR Article 10(7)). A file kept in another format is read against the six Annex II sections, because the Annex numbering follows the EU MDR (Regulation (EU) 2017/745).

Annex II and Annex III at a Glance

MDR Annex II has six sections, from the device description to verification and validation, IVDR Annex II also has six with performance data in Section 6, and Annex III of each regulation adds the post-market surveillance plan and reports. The table sets the parts of the file side by side.

The IVDR column names Sections 2 to 5 by number only; their wording is in IVDR Annex II.

MDR Annex II Section by Section

MDR Annex II lists what the file must contain in six sections, from the device description in Section 1 to verification and validation in Section 6. The section and point numbers below follow the consolidated MDR on EUR-Lex.

Device Description, Labels and Instructions for Use

Section 1.1 of MDR Annex II asks for 12 points, (a) to (l), including the Basic UDI-DI, the rationale for qualifying the product as a device, the risk class with the justification for the classification rule applied, any novel features, the variants and the materials. An indicative class with its Annex VIII rule can be worked out with the class finder for medical devices.

Section 2 asks for the complete set of labels and instructions for use in the languages accepted in the member states where the device is envisaged to be sold. The language rule itself sits in MDR Article 10(11) and IVDR Article 10(10): the information supplied is in the official Union language or languages determined by the member state where the device is made available to the user or patient.

Section 3: Design and Manufacturing Information

Section 3 describes how the device is designed and made and, under point (c), identifies every site where design and manufacturing take place, including suppliers and sub-contractors. Unique device identifiers are kept with the file as well: under MDR Article 27(7), the technical documentation keeps a list of all UDIs the manufacturer has assigned.

Sections 4 and 5: Conformity Demonstration and Risk Management

Section 4 shows how the device meets the general safety and performance requirements of Annex I: which requirements apply and why the others do not, the methods used, the harmonised standards, common specifications or other solutions applied, and the precise identity of the controlled documents that hold the evidence. The Annex I checklist itself is explained on the GSPR page listed in the table at the end of this page.

Section 5 holds the benefit-risk analysis and the risk management information. Under MDR Article 9(1) and IVDR Article 9(1), common specifications may also cover the technical documentation of Annexes II and III. Which standards give a presumption of conformity is set out under harmonised standards under the MDR and IVDR.

Section 6: Verification, Validation and Clinical Data

Section 6.1 holds the pre-clinical and clinical data: point (b) covers the results and analyses of biocompatibility, physical, chemical and microbiological characterisation, electrical safety and electromagnetic compatibility, software verification and validation, stability including shelf life, and performance and safety.

Where no new testing has been undertaken, the documentation incorporates a rationale for that decision (MDR Annex II Section 6.1(b)).

Points (c) and (d) add the clinical documents: the clinical evaluation plan and report under MDR Article 61(12) and Annex XIV Part A, and the post-market clinical follow-up (PMCF) plan and PMCF evaluation report, or a justification why PMCF is not applicable. The clinical evaluation report is part of the Annex II file for every device other than a custom-made device (MDR Article 61(12)), and how the report is built is set out under clinical evaluation under the MDR.

The Seven Specific Cases of Section 6.2

Section 6.2 adds documents for seven specific cases, points (a) to (g). The seven cases are listed below.

• (a) Devices incorporating a medicinal substance.
• (b) Devices made with tissues or cells of human or animal origin.
• (c) Devices made of substances that are absorbed or locally dispersed.
• (d) Devices containing CMR or endocrine-disrupting substances, with the justification for their presence.
• (e) Devices placed on the market sterile or in a defined microbiological condition.
• (f) Devices with a measuring function.
• (g) Devices to be connected to other devices.

Each point is tied to its case: a sterile device carries the point (e) documents, and a device with a measuring function the point (f) documents.

How IVDR Annex II Differs

IVDR Annex II keeps the six-section structure but asks for a more detailed statement of the intended purpose and replaces clinical data with performance data, stability data and software in Section 6. The two sections below, Section 1.1(c) and Section 6, set out these differences for a file built for an IVD. The regulation itself is described under the IVDR (Regulation (EU) 2017/746).

Describing the Device's Purpose in Section 1.1(c)

IVDR Annex II Section 1.1(c) requires the intended purpose to state what the device detects or measures, its function, the disorder, condition or risk factor concerned, whether it is automated, whether it is qualitative, semi-quantitative or quantitative, the specimen type, the testing population and the intended user. The function covers screening, monitoring, diagnosis, aid to diagnosis, prognosis, prediction or companion diagnostic.

For a companion diagnostic, Section 1.1(c) also asks for the target population and the associated medicinal product. This point is the IVDR counterpart of MDR Annex II Section 1.1. The full text is in the consolidated IVDR on EUR-Lex.

Section 6: Performance Data and Stability Claims

IVDR Annex II Section 6 is split into analytical performance (6.1), clinical performance (6.2), stability (6.3), software (6.4) and specific cases (6.5). Section 6.1.2 lists the analytical performance characteristics: accuracy of measurement, analytical sensitivity, analytical specificity, metrological traceability of calibrator and control material values, measuring range and the definition of the assay cut-off. Section 6.3 covers the claimed shelf life, in-use stability and shipping stability.

The performance evaluation report is part of the file under Section 6.2, and it includes both favourable and unfavourable data (IVDR Article 56(5); Annex XIII Section 1.3.3). It combines the scientific validity report, the analytical performance report and the clinical performance report with an assessment of those reports (IVDR Annex XIII Part A Section 1.3.2), and how it is built is set out under IVDR performance evaluation.

Annex III: The Plan and the Reports It Requires

Annex III, technical documentation on post-market surveillance, holds the post-market surveillance plan (MDR Article 84, IVDR Article 79) and the periodic safety update report (MDR Article 86, IVDR Article 81) or the post-market surveillance report (MDR Article 85, IVDR Article 80). Under MDR Annex III Section 1(a), the plan draws on six information sources: serious incidents, including PSUR information and field safety corrective actions; non-serious incidents and data on side-effects; trend reporting; literature, databases and registers; feedback and complaints; and public information on similar devices. The 10 minimum elements of the plan under MDR Annex III Section 1(b) are listed below.

• Proactive and systematic collection of information.
• Methods to assess the collected data.
• Indicators and threshold values for the reassessment of the benefit-risk analysis.
• Methods to investigate complaints.
• Trend reporting methods and the observation period.
• Communication with competent authorities, notified bodies, economic operators and users.
• Procedures to fulfil the post-market surveillance obligations.
• Corrective actions.
• Traceability tools.
• The PMCF plan, or a justification why PMCF is not applicable.

The post-market surveillance plan is part of the technical documentation for every MDR device other than a custom-made device (MDR Article 84) and for every IVD (IVDR Article 79). The MDR PSUR is part of the file for devices other than custom-made devices (MDR Article 86(1)). Under IVDR Annex III Section 1(b), the plan holds a post-market performance follow-up (PMPF) plan, or a justification why PMPF is not applicable, in place of the PMCF plan.

The headings of MDR Annex III Sections 1 and 2 were corrected by a corrigendum published in OJ L 334 of 27 December 2019. How the system behind the plan runs is set out under post-market surveillance under the MDR and IVDR.

What Notified Bodies Check in the Technical Documentation

A notified body assesses the technical documentation of class III and class D devices within the conformity assessment route of their class, of every class IIb implantable device and every companion diagnostic, and of a representative sample for the other classes it covers: under the MDR that is at least one device per generic device group in class IIb and per category of devices in class IIa, and under the IVDR the same for classes C and B (MDR Article 52(4) and (6), IVDR Article 48(7) and (9)). The table gives each class with its legal basis.

Every Device or a Representative Sample, by Class

Class III devices follow Annex IX, or Annex X with Annex XI (MDR Article 52(3)), and class D IVDs follow Annex IX Chapters I, II (except Section 5) and III, or Annex X with Annex XI (IVDR Article 48(3) to (6)). Their full routes are described on the two conformity assessment pages named in the table.

Companion diagnostics are the IVDR exception to sampling in class C: the notified body assesses the technical documentation of every device under Annex IX Sections 4.1 to 4.8 and 5.2 (IVDR Article 48(7), third subparagraph). Self-tests and near-patient tests of classes B, C and D also go through IVDR Annex IX Section 5.1, in addition to the route of their class.

Class IIb Implants Exempt from Per-Device Assessment

For class IIb implantable devices the notified body assesses the file of every device, except the well-established technologies listed in the second subparagraph of MDR Article 52(4), which are sampled per generic device group. The class itself is described under class IIb medical devices under the MDR.

Commission Delegated Regulation (EU) 2026/1359, adopted on 20 March 2026 and published in OJ L, 2026/1359, of 29 June 2026, has applied since 19 July 2026 and replaced that subparagraph. List (a), from sutures to connectors, is unchanged. List (b) adds 23 implant types: cannulas, catheters, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal obturators, radiography markers, fibre ligatures, transpalatal distractors, nails, anchors, spinal posterior fixations, textile braids, dental implants, orthodontic devices, dental barriers, and suspensory fixations and cinches. The delegated regulation does not change the legacy-device list of MDR Article 120(3a)(a).

MDCG 2019-13 rev.1 and the Choice of Sample

MDR Annex IX Section 2.3 requires the notified body, when choosing representative samples, to take into account the published MDCG guidance, and that guidance is MDCG 2019-13 rev.1 of December 2024 on sampling MDR class IIa and IIb and IVDR class B and C devices. The MDCG 2019-13 rev.1 document is filed under the topic "Notified bodies" in the Commission's MDCG list, as the current revision as of 6 November 2026.

MDCG guidance is not legally binding (MDR Articles 103 and 105, IVDR Articles 98 and 99), and notified bodies take it into consideration under Annex VII Section 1.6.2. The MDCG ongoing-guidance list in its January 2025 version names a revision of MDCG 2019-13 and an MDR notified body technical documentation assessment report as work items; neither is published guidance.

Language, Certificates and Fees

The documents submitted to the notified body are in an official Union language that the notified body's member state may require, or otherwise in any official Union language the notified body accepts (MDR Article 52(12), IVDR Article 48(12)). Public fee lists effective between 11 November 2024 and 1 January 2026 price a technical documentation assessment at EUR 3,250 to EUR 4,032 per day or EUR 410 per hour, and the lists are compared under notified body fees and timelines.

MDR Annex XII Chapter I point 4 lists the EU technical documentation assessment certificate among the five certificate types a notified body issues. The Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of the MDR, version 4 of 21 April 2026 and 92 pages long, comes from the notified-body association Team-NB, not from the MDCG.

Keeping the File: Retention, Updates and Authority Requests

MDR manufacturers keep the technical documentation for at least 10 years after the last device covered by the EU declaration of conformity is placed on the market, and for at least 15 years for implantable devices (MDR Article 10(8)); IVDR manufacturers keep it for at least 10 years (IVDR Article 10(7)). The manufacturer also keeps the file up to date (MDR and IVDR Article 10(4)).

Besides the summary on request described above, MDR Article 10(8) requires, for a manufacturer established outside the EU, that its authorised representative has the necessary documentation permanently available. That role is described under the EU authorised representative for medical devices.

MDR Annex IX Chapter III Section 7 sets the same periods, 10 years and 15 years for implantable devices, for the documentation of the Annex IX route.

Proposed Changes to the Documentation Rules

As of 6 November 2026, Commission proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)) is pending at the stage "Awaiting committee decision" in the European Parliament's SANT committee, with a draft report of 30 June 2026; it is not law. The stage and the past procedural events are recorded in the legislative observatory file.

The proposal would allow the technical documentation and its reports to be drawn up in a digital, structured, machine-readable format with version control, in a format agreed with the notified body. It would rename Annex II Section 6.1 "Non-clinical, pre-clinical and clinical data", adding in vitro, ex vivo and in silico testing and computational modelling, and it would remove the PMCF documents of Section 6.1(d) from Annex II. Every amending act and the proposal are listed under MDR and IVDR amendments.

Where Each Part of the File Is Covered in Detail

Nine pages explain the documents the file points to in more detail, from the Annex I checklist to the declaration of conformity. The table names each page and what it adds to the file.

What Technical Documentation Does Not Prove

A complete file is evidence, not a decision: conformity is shown through the conformity assessment route of each class. The file supports that route, from class I and class A devices without a notified body to the notified-body routes of class III and class D.

Is a Complete File a Certificate?

No: where a notified body is involved, it issues a certificate after its assessment, and the manufacturer then draws up the EU declaration of conformity and affixes the CE marking (MDR Article 10(6), IVDR Article 10(5)). The steps are set out under CE marking for medical devices and IVDs.

Why Devices Made for One Patient Follow Annex XIII Instead

Custom-made devices are outside MDR Article 10(4): their documentation follows MDR Annex XIII, the MDR PSUR for them sits in the Annex XIII Section 2 documentation, and the IVDR has no custom-made category. A custom-made device carries an Annex XIII statement, not the CE marking or an EU declaration of conformity.