Medical Devices Regulation

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.

What is a "Medical Device"?

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:

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 that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

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.

What are the essential safety requirements for Medical Devices?

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:

devices must be designed and manufactured in a way that when used under the conditions and for the purposes intended, they will not comprise the clinical condition or the safety of patients, or the safety and health of users or other persons;
the manufacturer of the medical devices has taken adequate measures in relation to the risks that cannot be eliminated, including informing users of the residual risks due to any shortcomings of the protection measures adopted; and
the devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage.

Additionally, each medical device must be accompanied by sufficient information to use the device safely.

What are the compliance and registration requirements?

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:

the address of the registered place of business and
the description of the devices concerned.

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 regulations

The new medical devices regulations (Regulation 2017/745 and Regulation 2017/746) supplement the current regulation with several new rules. These include:

the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these regulations,
improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification,
the strengthening of post-market surveillance requirements for manufacturers and
improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.