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Technical documentation — overview

Regulatory basis

The requirement to maintain technical documentation is in Schedule 3 and throughout Schedule 1 of the UK MDR 2002. There is no single document that specifies an exhaustive technical file structure, but MHRA guidance and UKAB expectations define the content standard. For higher-risk devices, the design dossier (a subset of the technical file) must be submitted to a UKAB.

Disclaimer

This site provides general information only. Always consult MHRA guidance and, for certified devices, your UKAB's expectations before finalising technical file structure.

What is the technical file?​

The technical file (sometimes called the technical documentation) is the complete set of documents that a manufacturer prepares and maintains to demonstrate that their device meets all applicable Essential Requirements of UK MDR 2002.

It is not a single document — it is a structured collection of documents, test reports, evaluation reports, design records, and supporting materials. The technical file:

  • Is prepared by the manufacturer (not the UKAB)
  • Must be available for inspection by MHRA at any time during or after market life
  • Must be available to the UKAB for assessment where required
  • Must be kept current throughout the device's market life
  • Must be retained for at least 5 years after the last device is manufactured (or 15 years for implantable devices in some interpretations — confirm with MHRA)

Technical file vs design dossier​

Under UK MDR 2002, two terms are used for technical documentation that are related but distinct:

TermApplies toContentsUKAB involvement
Technical fileAll devicesComplete documentation demonstrating ER conformityUKAB may review during assessment; must be available on request
Design dossierClass III, AIMD, IVD List A devicesA defined subset focused on device design — submitted to UKAB for examinationUKAB formally examines and issues Design Examination Certificate

The design dossier is a component of — not a replacement for — the technical file. Class III and AIMD manufacturers maintain the full technical file and submit the design dossier to the UKAB.

Technical file structure — core sections​

There is no mandated format, but the following structure is widely accepted and aligns with UKAB expectations:

Section 1 — Device description and specifications​

  • Device name, type, model references
  • Intended purpose and intended users
  • Intended patient population
  • Description of the device — how it works, its key components, accessories
  • Classification rationale (Schedule 2 rules applied)
  • List of novel features compared to predecessor devices
  • Reference to previous generations (if applicable)

Section 2 — Regulatory history​

  • Declaration of Conformity (current version)
  • UKCA mark authorisation (or CE certificate reference)
  • UKAB certificate(s) if applicable
  • MHRA registration reference
  • International regulatory status (CE, FDA clearance, TGA listing, etc.)

Section 3 — Essential Requirements checklist​

  • Completed ER checklist (Schedule 1 or Schedule 1A)
  • Cross-references to evidence sections

Section 4 — Labelling and IFU​

  • Current label design files (all language versions for GB market)
  • Current IFU (English version as minimum for GB)
  • Labelling compliance review (ER 18 checklist)
  • Translations (where applicable)

Section 5 — Risk management file​

  • Risk management plan
  • Hazard identification and risk estimation records
  • Risk control measures and their effectiveness
  • Residual risk evaluation
  • Overall benefit-risk evaluation
  • Risk management report
  • Post-market updates to the risk file

Section 6 — Design and development documentation​

  • Design input requirements
  • Design output (specifications, drawings, BOMs)
  • Design verification records (test reports demonstrating design outputs meet inputs)
  • Design validation records (confirming the device meets user needs and intended use)
  • Design review records
  • Design change history and change control records

Section 7 — Manufacturing information​

  • Manufacturing process description
  • Manufacturing site(s) identification
  • Critical suppliers and subcontractors
  • In-process controls and acceptance criteria
  • Final product release criteria and test records
  • Sterilisation process description and validation (if applicable)
  • Packaging validation (if applicable)

Section 8 — Pre-clinical and performance testing​

  • Biocompatibility evaluation (ISO 10993)
  • Electrical safety testing (IEC 60601-1 series) if active device
  • EMC testing (IEC 60601-1-2) if active device
  • Mechanical testing
  • Software documentation (IEC 62304) if applicable
  • Sterilisation validation
  • Shelf-life and stability data
  • Any other performance testing specific to device type

Section 9 — Clinical evaluation / performance evaluation​

  • Clinical Evaluation Plan (CEP)
  • Clinical Evaluation Report (CER) — with full literature data, equivalent device analysis, clinical study data
  • Post-Market Clinical Follow-up (PMCF) plan
  • PMCF reports (updated annually or as data becomes available)

For IVDs:

  • Performance Evaluation Plan (PEP)
  • Performance Evaluation Report (PER) — analytical and clinical performance data
  • Post-Market Performance Follow-up (PMPF) plan and reports

Section 10 — Post-market data​

  • Post-market surveillance plan and current PMS report
  • Complaint records (summary)
  • Vigilance reports submitted to MHRA
  • PSUR (where required)
  • Literature monitoring records
  • Post-market clinical follow-up / performance follow-up data

Design dossier — contents for Class III / AIMD​

For Class III and AIMD devices, the design dossier is the portion of the technical file submitted to the UKAB for design examination. It typically includes:

  1. General device description and intended purpose
  2. Design specifications — functional, performance, and safety requirements
  3. Drawings and diagrams (sufficient to demonstrate the design)
  4. Methods of manufacture — overview of critical manufacturing steps
  5. Essential Requirements checklist (or relevant subset)
  6. Risk analysis
  7. Solutions adopted to meet each applicable ER
  8. Results of design calculations
  9. Clinical investigations — protocols, results, conclusions
  10. Pre-clinical testing results
  11. Labelling and IFU drafts

The design dossier is a formal document submitted with the conformity assessment application. The UKAB issues a Design Examination Certificate if the dossier is satisfactory.

Language requirements​

All technical documentation submitted to MHRA or a UKAB for the GB market must be in English, or accompanied by a certified translation into English.

The IFU for devices placed on the GB market must include English. Manufacturers may include other language versions but English is mandatory.

Document control and versioning​

The technical file must be under document control:

  • Each document has a unique identifier, version number, and effective date
  • Changes are tracked and authorised through a formal change control process
  • Superseded versions are archived and accessible
  • The current version of each document is identifiable

This is typically managed within the manufacturer's ISO 13485 QMS.

Making the technical file available​

The manufacturer (or UKRP for non-UK manufacturers) must be able to provide the technical file — or the relevant portions of it — to:

  • MHRA on request during market surveillance or investigation
  • The UKAB during conformity assessment, surveillance audits, or on request
  • Serious incident investigation authorities as required

The file does not need to be held in the UK but must be accessible within a reasonable timeframe (MHRA guidance suggests this is typically a matter of days, not weeks).

Retention periods​

Device typeMinimum retention period
General medical devices5 years from last manufacturing date
Implantable devicesRecommended 15 years (confirm with MHRA)
IVDs5 years from last manufacturing date
AIMDsLifespan of the device — often >15 years

Manufacturers should also retain technical documentation for as long as the device remains in clinical use, even after production has ceased.

Official references​

ReferenceDescription
UK MDR 2002, Schedule 3Conformity assessment procedures including documentation requirements
UK MDR 2002, Schedule 1Essential Requirements cross-referenced in technical file
MHRA: Guidance on the UK MDR 2002Includes technical file guidance
EU MDD 93/42/EEC, Annex II/VSource of technical file requirements (for reference)
ISO 13485:2016, Section 4Document and record control requirements