Defibrillators

Amazon’s policies require that certain safety products sold through Amazon meet certification standards.

Defibrillators are a medical device for the purposes of the EU rules. For more information on EU laws on medical devices, go to Medical Devices. See below for further information about EU requirements for selling defibrillators on Amazon.

This material is for informational purposes only. It is not intended as legal advice.

Image and definition of a defibrillator

A defibrillator is a medical device that delivers a dose of electric current to the heart. This depolarizes a large amount of the heart muscle, ending the dysrhythmia. Subsequently, the body's natural pacemaker in the sinoatrial node of the heart is able to re-establish normal sinus rhythm.

To sell these products in the EU on Amazon, apply by submitting the following information to eu-life-safety-equipment@amazon.co.uk:

• Your company name
• Your vendor or seller ID
• Your email address
• Your phone number
• A list of ASINs you are applying to sell
• The country or countries where you would like to sell your product
• A clear product image that displays the model number, CE marking, and brand name
• The EC type examination certificate illustrating compliance to 93/42/EEC Medical Device Directive
• An image of the product manual in each language in which it is available
• The document issued by the manufacturer that proves the product is intended for end-consumers; this could be part of the instruction manual, or a separate declaration from manufacturer

You can find a list of NRTLs who might be able to help you with product certification on the Europe Compliance Solutions page.