Device description & specification
MDR Annex II, Section 1 and IVDR Annex II, Section 1. The device description and specification is the foundational section of technical documentation — it defines what the device is, what it does, and for whom.
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
Overview
The device description and specification section establishes the scope and identity of the technical documentation. Every other section — GSPR, risk management, clinical evaluation — flows from the statements made here. Getting the device description right is critical: an imprecise intended purpose creates ambiguity in every downstream document.
Required content — MDR Annex II §1
1.1 Device identity
- Device name: trade name, common name, and generic device group name
- Basic UDI-DI: the reference number that links all documentation to the specific device
- Model and type designations: all variants, configurations, and accessories within scope of the technical documentation
- Intended patient population: age range, gender, health status, conditions being treated or diagnosed
- Intended users: healthcare professionals (which specialty), lay users, or both
- Intended use environment: hospital, home, ambulance, laboratory, etc.
1.2 Intended purpose
This is the most critical element of the device description. The intended purpose must:
- Clearly state what the device does and for whom
- Specify the medical condition(s) it addresses
- Identify any contraindications or patient populations excluded from use
- Align exactly with the labelling, IFU, and promotional materials
The intended purpose drives classification, conformity assessment route, clinical evidence strategy, and GSPR applicability. Invest time in getting it precisely right. Vague intended purposes create regulatory problems downstream — and overly broad intended purposes require more extensive clinical evidence.
1.3 Principle of operation
A description of how the device works — its mechanism of action, the physical, chemical, mechanical, or other principles by which it achieves its intended purpose. For:
- Active devices: description of the energy source, conversion, and delivery mechanism
- Software: description of the algorithm, input data, output, and decision logic
- IVDs: description of the analytical principle (immunoassay, PCR, enzymatic, etc.) and how the signal is generated and quantified
1.4 Technical specifications
- Dimensions, weight, materials of construction
- Performance specifications (output parameters, accuracy, range, resolution)
- Electrical specifications (for active devices)
- Sterilisation method and sterility assurance level (for sterile devices)
- Shelf life and storage conditions
- Reuse information (single-use designation or maximum number of reuses with reprocessing instructions)
1.5 Accessories, combination devices, and systems
List of:
- Accessories specifically intended for use with the device
- Other devices or equipment the device is intended to be used in combination with
- Medicinal products or other substances the device is intended to be used with (for combination products)
1.6 Variants and generations
- Description of previous generations of the device (if applicable)
- Reference to the equivalent device (if used in the clinical evaluation)
- Description of variants or configurations included in this technical documentation
Required content — IVDR Annex II §1 additions
For IVDs, the device description must additionally include:
- The analyte(s) measured or detected
- Type of specimen(s) required (whole blood, serum, plasma, urine, etc.)
- Measurement range and units
- Intended use setting (laboratory, point of care, home use)
- For companion diagnostics: the therapeutic product and patient selection indication
Common mistakes to avoid
| Mistake | Consequence |
|---|---|
| Intended purpose is too vague (e.g. "for diagnosis of disease") | Inadequate — must specify the condition, population, and setting |
| Intended purpose differs between documents | Inconsistency is a critical finding in notified body reviews |
| Variants not listed | Undocumented variants may not legally benefit from the CE certificate |
| No clear statement of contraindications | GSPR and clinical evaluation gaps |
| Principal of operation is superficial | Notified bodies require enough detail to assess GSPR compliance independently |
Relationship to other technical documentation sections
The device description forms the reference framework for:
- GSPR table — applicability of each GSPR is determined by the device type and intended purpose stated here
- Risk management — hazard identification begins with the device description
- Clinical evaluation / performance evaluation — the clinical claims must align precisely with the intended purpose
- IFU and labelling — must be consistent with the intended purpose in the technical documentation
- Classification rationale — classification rules are applied to the intended purpose and device type
If the intended purpose changes — even slightly — a formal change control process must be initiated, and all affected technical documentation sections reviewed.
Related pages
- Technical documentation — overview
- GSPR cross-reference
- Risk management
- Clinical evaluation
- UDI overview
Official references
| Reference | Description |
|---|---|
| MDR Annex II, Section 1 | Device description and specification |
| IVDR Annex II, Section 1 | IVD equivalent |
| MDR Art. 2(24) | Definition of intended purpose |
| MDCG 2020-6 | Technical documentation templates |
| MDCG 2022-2 | Guidance on intended purpose |