How does a manufacturer comply with requirements?

 This will include amongst others, as relevant:

• Risk management
• Clinical data
• Sterilization
• Biological safety
• Electrical safety
• Electromagnetic compatibility
• Labelling and Instructions

Where available, relevant standards may be used to demonstrate how many of the requirements have been met.

In addition, guidance on the Evaluation of Clinical Data may be particularly useful.

Manufacturers will also normally have to have in place a quality system which meets the requirements of EN ISO 13485 : 2003 (Medical devices. Quality management systems. Requirements for regulatory purposes).

Before manufacturers can place their products on the market they will also need to have their quality systems and technical documentation reviewed by a Notified body (link to NB section). The body will need to assure itself that all relevant requirements have been met before issuing relevant certification. Manufacturers can then place the CE marking on their products to demonstrate their compliance with the requirements.