If you are selling items that are or might be medical devices (including accessories of medical devices), you should consult Directive 93/42/EEC on medical devices (the “MDD”). The MDD contains the EU requirements for selling medical devices, including device classification, compliance requirements and registration obligations. Note that in vitro diagnostic medical devices and implantable devices are not covered by the MDD, but they do fall within the scope of two other directives: Directive 98/79 and Directive 90/385.
The MDD, Directive 98/79 and Directive 90/385 will be replaced by two new regulations. The new regulation on medical devices will enter into force, following a transition period, on May 26, 2020. The new regulation on in vitro diagnostic medical devices will enter into force, following a transition period, on May 26, 2022.
It is your responsibility to comply with the rules and regulations for medical devices. 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, as well as any national laws and regulations.
Medical devices range from plasters to stethoscopes, from thermometers to ventilators, to pacemakers and more. The MDD defines a medical device is 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:
The MDD also applies to “accessories,” which are defined as any article that, whilst not being a device, is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.
All medical devices and accessories must meet the “essential requirements” set out in Annex I of the MDD. In general terms, these requirements specify that:
Additionally, each medical device must be accompanied by sufficient information to use the device safely.
Each medical device must undergo a conformity assessment to ensure that it complies with implementing legislation of the MDD. In addition, each medical device must bear a CE mark confirming that the device has undergone and passed the conformity assessment and the relevant Notified Body’s identification number. The CE mark must appear in a visible, legible and indelible form on the device or its sterile pack, and on the instructions for use. Labelling must be in the language(s) of the Member State(s) in which the product is available for sale or supply.
Furthermore, any manufacturers who sell a device in accordance with the conformity assessment procedures are required to inform the competent authorities of the Member State in which they have their registered place of business of:
If the manufacturer is established in the EU, they must label the product with their name and address. If a manufacturer does not have a registered place of business in Member State, the manufacturer is required to designate a single authorised representative in the European Union. This authorised representative must be mentioned on the product including the respective symbol.
Amazon does not sell professional use only Medical Devices. Check with the manufacturer/instructions for use before listing such products for sale on Amazon.
The new medical devices regulations (Regulation 2017/745 and Regulation 2017/746) supplement the current regulation with several new rules. These include:
We strongly encourage you to visit the following sites for more information on rules and regulations that apply to medical devices: