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This article applies to selling in: Italy

Defibrillators

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

EU requirements: Defibrillators are a medical device for the purposes of the EU rules. For more information on EU laws on medical devices please see this help page. Please see below for further information about EU requirements for selling defibrillators on Amazon.

UK requirements: Defibrillators are a medical device for the purposes of the UK rules. For more information on EU laws on medical devices please see this help page. Please see below for further information about UK Requirements for selling defibrillators on Amazon. Different rules apply to goods you sell in: (1) Great Britain (England, Scotland and Wales); and (2) Northern Ireland.

This material is for informational purposes only. It is not intended as legal advice. We encourage you to consult your legal counsel if you have questions about the laws and regulations concerning your product and how you will be affected by the upcoming changes. This material only reflects the position at the date of writing and requirements in the EU and the UK may change – particularly in light of the developing position with Brexit and expected changes to the UK’s approach to regulating medicines and medical devices. You should refer to current UK Brexit guidance about your products (see below) to learn more about changes that may affect you following the end of the transition period.

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.

I. EU Requirements

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.

Note: By applying to sell these products, you certify that all materials that you submit are true, authentic, and accurate. Amazon may remove your selling privileges for failing to meet these requirements.

II. UK Requirements

To sell products on Amazon first made available in the UK or EU on or before December 31 2020, 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
  • 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 UK plug
  • 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

To sell products on Amazon first made available in Great Britain (England, Scotland and Wales, “GB”) on or before December 31, 2020, 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
  • A clear product image that displays the model number, UKCA marking, and brand name
  • The UK type examination certificate illustrating compliance to the applicable rules as amended by the UK Medical Devices (Amendment etc.) (EU Exit) Regulations 2019/791
  • An image of the UK plug
  • 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

Northern Ireland

Please note that different rules will apply in Northern Ireland (“NI”) from January 1, 2021 as a result of the Northern Ireland Protocol. In particular:

  • You should ensure that products meet EU requirements and that you use the CE mark.
  • You are an importer if you are established in the EU or NI and you sell products from a country outside of the EU and Northern Ireland (including from GB) into NI. Products sold in NI should be marked with details of any EU / NI based importer.
  • Authorised representatives can be based in NI or the EU. From July 16, 2021, new rules come into force under EU Regulation 2019/1020 and some businesses may need to appoint a responsible person in the EU or NI to carry out compliance functions (if there is no other entity in the supply chain who is able to carry out the functions). Further guidance on the new rules will be made available by the UK Government.
  • If you are using a UK body to carry out mandatory third-party conformity assessment, you will need to apply a UKNI marking as well as a CE mark to products placed in NI from January 1, 2021. Goods with the CE and UKNI marking can’t be sold in the EU. You do not need to use the UKNI marking if you self-certify compliance or use an EU body to carry out a mandatory third-party assessment.
  • “Qualifying Northern Ireland goods” will be able to be sold in GB with the CE mark. The UK Government is issuing guidance on how this will work.

BREXIT: UK Government Guidance

The UK Government has released guidance outlining changes that will apply from January 1, 2021 in respect of the sale of medical devices in GB. Key changes include:

  • All medical devices and in vitro diagnostic medical devices sold in GB will need to be registered with the MHRA. Grace periods will apply for certain categories of devices:
    • 4 months: Class IIIs and Class IIb implantable medical devices and all active implantable medical devices;
    • 8 months: other Class IIb and all Class IIa medical devices; and
    • 12 months: Class I medical devices.
  • Manufacturers based outside the UK who want to sell a medical device in GB will need to establish a UK Responsible Person to take responsibility for the product in the UK.
  • Between January 1, 2021 and June 30, 2023, either the CE or the UKCA mark can be used. Only the UKCA mark will be recognised for all medical devices after June 30, 2023.
  • Certificates issued by European Economic Area based Notified Bodies will continue to be valid for GB sales until June 30, 2023.
  • There are special status rules for Northern Ireland.

We encourage you to review this guidance (linked below), alongside any other specific UK Government Guidance that applies to your product. You should consult your legal counsel if you have questions about how the laws and regulations apply to your products from January 1, 2021.

Brexit guidance for GB and NI be found here:

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

Note: By applying to sell these products you certify that all materials you submit are true, authentic and accurate. Amazon may remove your selling privileges for failing to meet these requirements.

Additional Information

We strongly encourage you to visit the following UK Government websites for more information on rules and regulations that apply to medical devices.

The September 1, 2020 Brexit guidance for Medical Devices referred to above can be found here:

We also encourage you to visit the Business Companion website, which contains guidance on UK product compliance rules:

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