1. Cover Page (Company, Product/Product Group, Document ID)

2. Index

3. EC declaration of conformity and classification.

4. Name and address of the Manufacturer/European Representative and Manufacturing Plants


5. Product description including:

All variants

Intended clinical use

Indications / contraindications

Operating instructions / warnings / precautions

Photographs highlighting the product, photographs highlighting the usage

Brochures, advertising, catalogue sheets, marketing claims


6. Product specification including:

Parts list

Drawings, assembly drawings

Sub-assembly drawings

Drawings of components

Specifications of materials used including data sheets

List of standards applied

Manufacturing specifications

Sterilisation specifications (if required)

Packaging specifications

QA specifications (QC specs., in-process controls etc.)


Accompanying documents

Package insert

Instructions for Use

Service Manual


7. Product verification including:

Testing data and reports

Functionality studies

Wet lab or bench top testing

Materials certificates / reports on biological tests

EMC testing and certificates

Validation of the packaging / ageing studies

Compatibility studies (connection to other devices)

Risk analysis (ISO 14971)

List of requirements (Annex 1) indicating cross-reference with documentation

Clinical Data