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1. Product Classification:
1. Confirm non-sterile
2. Confirm non-measuring
3. Run MDA's classification guidance computer software programme
4. Confirm classification with European Union Council Directive 93/42/EEC (The Medical Devices Directive)
2. Technical Documentation:
1. List technical documentation required, its content, use and any cross referencing required.
2. Confirm device description and ensure that it does not change the classification.
3. list raw materials & component specifications, including any COC's (Certificates of Conformity) from suppliers.
4. Identify any intermediate product and sub-assembly specifications.
5. Define final product specifications.
3. Packaging & labelling:
1. Specify labeling including artwork for CE Mark.
2. If required (refer to section 14) specify artwork for naming EU Authorised Representative name, contact telephone & fax numbers, etc.
3. Specify IFU's (Instruction for Use Leaflets) details.
4. Specify packaging requirements.
5. Identify language requirements.
6. Confirm shipping & transportation specifications.
4. Design:
1. Confirm how the device's design input is verified against the manufactured device.
2. list qualification tests used.
3. Confirm design calculations used.
4. list any and all device connections.
5. Define "Statement of Intended Use".
6. Hazard Evaluation:
1. Identify all potential hazards.
7. Risk Analysis:
1. Analyse the risk of each hazard occuring.
2. Access the level of harm likely to occur. i.e. seriousness.
3. confirm actions to remove those hazards considered likely to cause harm or injury to the patient, user or others.
4. Identify methods to mitigate any harm or injury to the patient, user or others.
8. Biocompatibility:
1. Assess the devices compatibility with:
1. The patient. i.e. contact with the skin.
2. With materials, compnents, sub-assemblies and other connecting devices.
2. Compile and review existing data and test results.
3. Confirm the application in full with the relevant product grouping harmonised standards.
9. Essential Reuirements:
1. Complete Essential requirements and confirm compliance with them.
10. Clinical Data:
1. List records of relevant experience.
2. Identify other published experiences.
3. Show supporting test results.
4. Show supporting conclusions.
11. Records: (results):
1. Show that the manufacturing and test records demonstrate compliance with defined procedures and specifications.
12. Post Market Survellience:
1. Confirm method and or procedure for positively capturing all feedback when and after introducing the device into the market.
13. Corrective & Preventive Action:
1. Implement a documented procedure to review the experience gained from devices in the market and implement any necessary corrective action, commensurate with the nature and the risks invloved with the device.
14. Appointment of an EU Authorised Representative.
15. Registration of the device:
1. Identify the Competent Authority.
2. Register the device with the Competent Authority. (or instruct your EU Authorised Representative to make the registration).
16. CE Mark: CE Mark the Device.
17. EC Declaration of Conformity: Use our guidance template to complete your Declaration of Conformity.

Self Declaration Kit:
If you have difficulty in using the above guidance for your Self Declaration process, you can order our S.D. Kit, which includes recommended procedures, help with the Essential Requirements and many other detailed advisory notes to guide you through Your Self Declaration Process.

Purchase a Self Declaration Kit

If you have purchased our Self Declaration Kit and are experiencing any difficulties email our Technical Specialist below, explain what the problems is and we will contact you with help.