EU requirements: If you are selling items in the EU 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.
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, 2021. 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 MDD for medical devices sold in the EU. You must also comply with laws and regulations in EU Member States.
Please see below for further information about EU requirements.
UK requirements: If you are selling items in the UK that are or might be medical devices (including accessories of medical devices), you should consult the Medical Devices Regulations 2002 SI 2002/618 (the “UK MDR”). The UK MDR contains the UK requirements for selling medical devices, including device classification, compliance requirements, and registration obligations. Please note that in vitro diagnostic medical devices and implantable devices are also covered by the UK MDR, but the provisions regulating these sectors are not discussed in this material.
The UK MDR implemented three EU Directives (Directive 90/385, Directive 93/42/EEC and Directive 98/79) whilst the UK was still a member of the EU. These EU directives have been replaced at an EU-level by two new EU Regulations. The new EU Regulation on medical devices will apply in all EU Member States, following a transition period, on 26 May 2021. The new EU Regulation on in vitro diagnostic medical devices will apply in all EU Member States, following a transition period, on 26 May 2022.
From January 1, 2021, an amended version of the UK MDR applies to medical devices and in vitro diagnostic medical devices as a result of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019/791. Further, at the time of writing, a draft of the Medicines and Medical Devices is currently being considered by Parliament which may further adapt the UK’s regulatory regime. Different rules apply to goods you sell in: (1) Great Britain (England, Scotland and Wales); and (2) Northern Ireland.
It is your responsibility to comply with the UK requirements for medical devices sold in the UK. If you also sell medical devices on Amazon EU website(s), then you must also comply with laws and regulations in EU Member States.
Please see below for further information about UK Requirements.
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. You should refer to current UK Brexit guidance about your products to learn more about changes that may affect you from January 1, 2021.
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 is defined as an article which 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:
In addition, each medical device must be accompanied by sufficient information to use the device safely.
Each medical device must undergo the appropriate conformity assessment to ensure 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. 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.
Furthermore, any manufacturer who sells a device in accordance with the conformity assessment procedures is required to inform the competent authorities of the Member State in which he has his registered place of business of:
If a manufacturer does not have a registered place of business in Member State, the manufacturer is required to designate a single authorized representative in the European Union.
Up until December 31, 2020, if a manufacturer does not have a registered place of business in the EU the manufacturer is required to designate a person established in the UK as the UK Responsible Person, to act on their behalf in relation to manufacturer obligations under the UK MDR.
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:
The UK MDR applies to all products sold in the UK, but the provisions apply differently to Great Britain (England, Scotland and Wales, “GB”) and Northern Ireland. You can read more about the position in Northern Ireland (“NI”) below.
Medical devices range from plasters to stethoscopes to thermometers to ventilators to pacemakers and more. The UK MDR defines a “medical device” as an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which is:
It includes devices intended to administer a medicinal product or which incorporate a substance (that forms an integral part of that device), which would be a medicinal product if used separately and have a similar impact on the body.
The UK MDR also applies to “accessories”. An accessory is defined as an article which, whilst not being a medical device, is intended specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the medical device intended by its manufacturer.
All medical devices (and accessories) must meet the “essential requirements” set out in Annex I of EU Directive 93/42/EEC (as immediately before January 31, 2021).
In general terms, these requirements specify that:
In addition, each medical device must be accompanied by sufficient information to use the device safely.
Each medical device must undergo the appropriate conformity assessment to ensure it complies with implementing legislation of the UK MDR, where applicable. In addition, each medical device must bear a CE mark confirming that the device has undergone and passed the conformity assessment. 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. In the future, a UK-specific compliance mark may be required.
Furthermore, any manufacturer who sells certain medical devices in the UK, under his own name and with a registered place of business in the UK, is required to register with the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) and provide details of:
Please note that different rules apply in NI from 1 January 2021 as a result of the Northern Ireland Protocol. In particular:
The UK Government has released guidance outlining changes that apply from 1 January 2021 in respect of the sale of medical devices in Great Britain, meaning England, Scotland and Wales, (“GB”). Key changes include:
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
The Brexit guidance can be found here:
We strongly encourage you to visit the following UK Government websites for more information on rules and regulations that apply to medical devices.
We also encourage you to visit the Business Companion website, which contains guidance on UK product compliance rules: