Design & manufacturing information
Design and manufacturing information requirements derive from the conformity assessment procedures in Schedule 3, UK MDR 2002 and the QMS requirements of ISO 13485. For Class III devices and AIMDs, the design dossier submitted to the UKAB must contain comprehensive design information.
Design controls: the ISO 13485 framework
Under ISO 13485 (the QMS standard MHRA expects manufacturers to use), design and development is controlled through a systematic process:
Design Planning → Design Inputs → Design Outputs
│ │ │
│ │ ▼
│ │ Design Verification
│ │ │
│ │ ▼
│ │ Design Validation
│ │ │
│ └───────────────┘
│ │
▼ ▼
Design Transfer Design Review
(to manufacturing) (at key stage gates)
│
▼
Design Changes (controlled throughout lifecycle)
All stages must be documented and retained as part of the design history file (DHF), which forms the core of the technical documentation.
Design inputs
Design inputs are the requirements the device must meet. They include:
- Functional requirements (what the device must do)
- Performance requirements (how well it must do it)
- Safety requirements (what hazards must be controlled)
- Regulatory requirements (Essential Requirements, applicable standards)
- User requirements (usability, intended user environment)
- Interface requirements (compatibility with other devices, accessories, infrastructure)
Design inputs must be documented, reviewed, and approved before design work begins. Ambiguous or incomplete design inputs are a leading cause of later design deficiencies.
Design outputs
Design outputs are the deliverables that result from the design process — documents and records that define the final device:
- Engineering drawings and specifications
- Software design specifications
- Bill of materials (BoM)
- Manufacturing instructions
- Inspection and test specifications
- Packaging specifications
- Labelling specifications
- Sterilisation specifications
Design outputs must demonstrate that all design inputs have been addressed.
Design verification
Verification answers: Did we build the device right? — i.e., does the design output meet the design input requirements?
Verification activities typically include:
- Bench testing against performance specifications
- Environmental testing (temperature, humidity, vibration, shock)
- Electrical safety testing (IEC 60601 series for active devices)
- Electromagnetic compatibility (EMC) testing
- Software testing (IEC 62304 — unit, integration, system testing)
- Dimensional and material inspection
- Sterility testing and bioburden testing
All verification test reports must be retained in the technical file.
Design validation
Validation answers: Did we build the right device? — i.e., does the device meet user needs and the intended purpose when used in actual or simulated conditions?
Validation activities include:
- Usability/human factors engineering studies (IEC 62366)
- Simulated use testing (in a representative clinical environment)
- Clinical evaluation (for the clinical performance claim)
- Performance evaluation (for IVDs)
- Animal studies or cadaveric studies (where applicable for implants)
Validation must demonstrate that the device performs as intended by real users in the intended use environment.
Manufacturing process documentation
The technical file must contain sufficient information about the manufacturing process to demonstrate that the production method consistently produces devices conforming to the design specifications:
- Process flow diagrams — overview of manufacturing steps
- Manufacturing instructions — step-by-step procedures for critical processes
- Critical process parameters — defined limits for temperature, pressure, time, speed, etc. that affect product quality
- In-process controls — inspection or testing steps within the manufacturing process
- Special processes — processes whose outputs cannot be fully verified by subsequent inspection (e.g., welding, sterilisation, injection moulding) must be validated (process validation records)
- Manufacturing site information — address of each manufacturing site; relevant regulatory status
Sterilisation documentation
For sterile devices, the technical file must include:
- Sterilisation method and rationale
- Sterilisation validation records (e.g., ISO 11135 for EO, ISO 11137 for radiation)
- Sterility Assurance Level achieved (typically SAL 10⁻⁶)
- Revalidation schedule and records
- Packaging validation (ISO 11607)
Pre-clinical test reports
All pre-clinical testing that contributes to demonstrating Essential Requirements conformity must be documented in the technical file:
| Test category | Applicable standards | ER addressed |
|---|---|---|
| Biocompatibility | ISO 10993 series | ER 7 |
| Sterilisation validation | ISO 11135, 11137, 11138 | ER 8 |
| Electrical safety | IEC 60601-1 and applicable collateral/particular standards | ER 13 |
| EMC | IEC 60601-1-2 | ER 13 |
| Mechanical performance | Device-specific standards (ISO, EN, ASTM) | ER 3, 4 |
| Software | IEC 62304, IEC 82304 | ER 14 |
| Usability | IEC 62366-1 | ER 1, 2 |
| Shelf life / stability | ASTM F1980 (accelerated ageing) | ER 4, 5 |
| Packaging | ISO 11607 | ER 5, 8 |
| Animal studies | GLP requirements where applicable | ER 2, 3 |
Test reports from accredited test laboratories carry more weight but are not mandatory — in-house testing to applicable standards is acceptable if the in-house laboratory is appropriately qualified and documented.
Design changes and change control
Any changes to the device design — materials, components, manufacturing process, software, labelling — must go through a documented change control process:
- Identify the change and its scope
- Assess the potential impact on Essential Requirements conformity
- Determine if re-verification, re-validation, or UKAB notification is required
- Implement the change with appropriate documentation
- Update the technical file (including ER checklist, risk file, clinical evaluation if affected)
- Issue a revised Declaration of Conformity if the change affects the DoC
- Notify the UKAB if the change affects a certified element (QMS certificate scope, Design Examination Certificate)
Related pages
- Technical documentation overview
- Device description & specifications
- Risk management (ISO 14971)
- Clinical evaluation summary
- Essential Requirements overview
Official references
| Reference | Description |
|---|---|
| ISO 13485:2016, Clause 7.3 | Design and development requirements |
| ISO 14971:2019 | Risk management — integrated with design process |
| IEC 62366-1:2015 | Usability engineering for medical devices |
| IEC 62304:2006+AMD1:2015 | Software lifecycle processes |
| EU MDR 2017/745, Annex II | EU technical documentation requirements (detailed reference) |
| MHRA: Guidance on the UK MDR 2002 | General technical file guidance |