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EEA/EU/UK CFS or FSC:
Certificate of Free Sale (Free Sales Certificate)

Certificate of Free Sale (or sometimes called Free Sales Certificate), how to acquire one for medical devices issued in Europe, i.e. in the EEA/EU/EC such as in the UK?

A Certificate of Free Sale (CFS), or sometimes called Free Sales Certificate (FSC), for medical devices issued in Europe, eg. in the EEA/EU/EC such as in the UK, is a certificate issued by a competent authority, such as the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK, certifying that a medical device has been affixed with the CE mark (CE marking) under the following 3 EU/EC directives which were transposed into UK legislation (UK medical devices regulations, as amended)

  • Active Implantable Medical Device Directive, AIMDD (90/383/EEC)
  • (General) Medical Device Directive, MDD (93/42/EEC)
  • In Vitro Diagnostic Medical Device Directive, IVDMDD (98/79/EC)
and therefore may be freely sold in all member states of the European Economic Area (EEA*) including the United Kingdom. The United Kingdom is made up of England, Scotland, Wales and Northern Ireland.

A UK Certificate of Free Sale is issued for medical devices made by either a UK-based manufacturer or by a non-EU manufacturer who has appointed a UK-based company such as Wellkang as the European Authorised Representative, i.e. the EC Rep. Many non-EEA countries and regions such as: Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, Peru, Ecuador, Venezuela; Bangladesh, Hong Kong, India, Indonesia, Malaysia, Pakistan, Philippines, Sri Lanka, Taiwan, Thailand; Bahrain, Egypt, Iran, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, United Arab Emirates (UAE); Serbia, South Africa, etc require or accept a Certificate of Free Sale issued by an EEA authority such as the MHRA in the UK as part of the supporting documents for the local market entrance authorisation.

A Certificate of Free Sales needs often further legalization and/or authentication by Dept. of Foreign Affairs, and/or, Chambers of commerce, and/or Embassy/Consulate, where applicable, in order to be used/accepted legally by the authority in the target country.

Below is an example of a Certificate of Free Sale issued in the UK for medical devices (made in the USA by an American manufacturer whose Authorised Representative is Wellkang Ltd, a UK-based company) for export to the market of Saudi Arabia. If you click on the Certificate, you can also view another example of a Certificate of Free Sale issued in the UK for IVD devices (made in Japan by a Japanese manufacturer whose Authorised Representative is also Wellkang Ltd) for export to the market of Iran

Click to view an example of a Certificate of Free Sale issued in the UK for medical devices (made in the USA by an American manufacturer whose Authorised Representative is Wellkang Ltd, a UK-based company) to be exported to the market of Saudi Arabia.


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* The European Economic Area (EEA):

The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EEA single market.

Switzerland is a member of EFTA, but neither an EU nor EEA member. It however is still part of the single market.


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Is my product a Medical Device (MD), an In Vitro Diagnostic Medical Device (IVD) or an Active Implantable Medical Device (AIMD)?

A Medical Device (MD)
is defined in Directive (93/42/EEC) as: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means.

Attention:
According to Directive 2007/47/EC which, will become mandatory on 21 March 2010, has amended the Directive 93/42/EEC, Medical Device means: any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means.

For a number of products it is not clear if they are medical devices or not. There are a number of examples of products that may or may not be medical devices depending on the Intended Purpose for Use, assigned by the manufacturer to the products.

The following Toiletry and Cosmetics Products can also be Medical Devices if a medical claim is being made by the manufacturer for the device, although these products are usually not Medical Devices:

  • tooth brushes, dental sticks, dental floss, dental chewing gums;
  • baby nappies, hygiene tampons, mattress protectors;
  • contact lenses intended to provide colour to the eyes;
  • instruments for tattooing;
  • deodorants for use with devices;
  • wigs.

An In Vitro Diagnostic Medical Device (IVD)
is defined in Directive (98/79/EC) as: any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
  • concerning a physiological or pathological state, or
  • concerning a congenital abnormality, or
  • to determine the safety and compatibility with potential recipients, or
  • to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. 'Specimen receptacles` are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;


An Active Implantable Medical Device (AIMD)
is defined in AIMDD Directive (90/383/EEC) as:
"Any medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure".

According to the directive, a device is ‘active’ if it relies for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity. This includes, for instance, devices activated by means of pressure, unless this effect is achieved by energy resulting from the patient’s body. The definition implies that the function of the device involves using the source of power to perform useful work. Mere transmission of heat, light, pressure or vibration does not mean that a device is active.

    Examples of types of devices normally covered by this directive include:
  • implantable cardiac pacemakers
  • implantable defibrillators
  • leads, electrodes, adaptors for the above
  • implantable nerve stimulators
  • bladder stimulators
  • sphincter stimulators
  • diaphragm stimulators
  • cochlear implants
  • implantable active drug administration devices
  • catheters, sensors for active drug administration devices

FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices
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About CE Marking:

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