Requirements for the Medical Devices Regulation and related legislation

This material is for informational purposes only. It is not intended as legal advice. We recommend that you consult your legal counsel if you have any questions about the upcoming changes in the laws and regulations, and how they affect you and your product. This material only reflects the current regulations as the requirements in the EU and the UK can change.

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 Regulation (EU) 2017/745 on medical devices (the “MDR”). This regulation contains the EU requirements for selling medical devices, including device classification, compliance requirements, and registration obligations.

It is your responsibility to comply with the MDR for medical devices sold in the EU. You must also comply with laws and regulations in EU Member States.

Note: In vitro diagnostic medical devices and implantable devices are not covered by the MDR, but fall within the scope of Regulation (EU) 2017/746 (the “IVDR”).

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 UK Medical Devices Regulation 2002 (“UK MDR”). The UK MDR contains the UK requirements for selling medical devices, including device classification, compliance requirements, and registration obligations. 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.

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 such as, Amendment (EU Exit) Regulations 2019/791. 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 VegaVend EU website(s), then you must also comply with laws and regulations in EU Member States.

The MDD, Directive 98/79 and Directive 90/385 will be replaced by two new regulations. The new regulation on medical devices: Medical Device Regulation 2017/745 (the EU “MDR”) 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 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.

For more information about EU requirements, see the following:.

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. Until 31 December 2020, medical devices can be sold in the UK under the UK MDR or the new EU Regulations.

After 31 December 2020, an amended version of the UK MDR will apply 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 Bill 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 VegaVend 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 – particularly in respect of the latter 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.

EU requirements

What is a “medical device”?

Medical devices range from plasters to stethoscopes, from thermometers to ventilators, to pacemakers and more. The MDR defines a medical device as 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 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 or diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap or investigation, replacement or modification of the anatomy or of a physiological process, or control of conception. Finally, a medical device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which can be assisted in its function by such means.

The MDR also applies to “accessories” which are articles that whilst not being a medical device, are intended by its manufacturer to be used together with a medical device to specifically enable the device to be used in accordance with its intended purpose.

What are the essential safety requirements for medical devices?

All medical devices (and accessories) must meet the “requirements” set out in Annex I of the MDR.

In general terms, these requirements specify that:

1. devices must be designed and manufactured in a way, that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or other persons.
2. the manufacturer of the medical devices must take 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
3. 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.
4. certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices are included under the scope of these regulations.

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 the appropriate conformity assessment to ensure it complies with implementing legislation of the MDR. Additionally, 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 must inform the competent authorities of the Member State in which he has his registered place of business of:

1. The address of the registered place of business
2. The description of the devices concerned

If a manufacturer does not have a registered place of business in Member State, the manufacturer must designate a single authorised representative in the European Union.

Note: VegaVend’s internal policy prohibits listing certain medical devices. For more information, go to Medical Devices.

VegaVend and the MDR or its related regulations

As a distributor of medical devices (FBV), VegaVend falls under the scope of the MDR and has approved certain fulfilment centres as medical device eligible. Under the governing legislation, medical devices cannot be stored in any fulfilment centre outside of this list. Note that the number of medical devices eligible fulfilment centres is dynamic and changes frequently, new fulfilment centres as added as soon as they are qualified as eligible.

Temperature restrictive medical device

Some medical devices are designed by the manufacturer which must be kept under or between certain temperatures. Note that VegaVend does not have the capability of safely storing medical devices which must be kept under 15 degrees Celsius or its Fahrenheit equivalent.

In Vitro Diagnostic medical devices (IVDR)

EU requirements: If you are selling items in the EU that are or might be in vitro diagnostic medical devices you should consult Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the “IVDR”). This regulation contains the EU requirements for selling in vitro diagnostic medical devices, including device classification, compliance requirements, and registration obligations.

It is your responsibility to comply with the IVDR for in vitro diagnostic medical devices sold in the EU. You must also comply with laws and regulations in EU Member States.

What is an “in vitro diagnostic medical device”?

An in vitro diagnostic medical device is a medical device intended by the manufacturer to be used in vitro for the examination of human specimens to provide the following information:

• concerning a physiological or pathological process or state.
• concerning congenital physical or mental impairments.
• concerning the predisposition to a medical condition or a disease.
• to determine the safety and compatibility with potential recipients.
• to predict treatment response or reactions.
• to define or monitoring therapeutic measures.

UK Requirements

Where does the UK MDR apply?

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.

What is a “medical device” under the UK MDR?

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:

• 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, or
  • control of conception; and
• does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means.

It includes devices intended to administer a medicinal product or which incorporates 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” which is an article that 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.

What are the Essential Safety Requirements for Medical Devices?

All medical devices (and accessories) must meet the “requirements” set out in Annex I of the UK MDR.

In general terms, the UK MDR specifies:

1. A new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the Great Britain market.
2. All medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market.
3. If you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration.
4. CE marking will continue to be recognised in Great Britain until June 30, 2023.
5. Certificates issued by EU-recognised notified bodies will continue to be valid for the Great Britain market until June 30, 2023.
6. Certificates issued by EU-recognised notified bodies will continue to be valid for the Great Britain market until June 30, 2023.

What are the Compliance and Registration Requirements?

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. From 1 January 2021, the new UKCA mark can be used. From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market.

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:

1. The address of their registered place of business in the UK
2. The description of the devices concerned

Registrations in Great Britain

All medical devices, including IVDs, custom-made devices and systems or procedure packs must be registered with the MHRA before being placed on the Great Britain market. In Great Britain (England, Wales and Scotland), devices must conform to the UK MDR 2002, the EU MDR (until June 30, 2023), or the EU IVDR (until June 30, 2023) to be registered with the MHRA. Additionally, devices that have been CE marked under the EU MDD, EU AIMDD or EU IVDD will continue to be accepted on the Great Britain market until June 30, 2023, if their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVDR.

The MHRA will only accept registration of devices from manufacturers where the manufacturer is based in the UK. If the manufacturer is based outside the UK, they must appoint a UK Responsible Person.

Failure to register your devices will mean that you are unable to lawfully place your device on the Great Britain market.

Northern Ireland

There are different rules for listing medical devices on the Northern Ireland market from the ones applicable to Great Britain. Key requirements include:

• CE marking is required for the Northern Ireland market. Additionally, the UKNI indication is required if a UK notified body undertakes mandatory third-party conformity assessment.
• certain medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Northern Ireland market need to be registered with the MHRA.
• when placing devices on the Northern Ireland market, Great Britain-based manufacturers must appoint an EU or Northern Ireland-based authorised representative.

Additional Information

We strongly encourage you to visit the following sites for more information on rules and regulations that apply to medical devices:

• European Commission Medical Devices homepage: https://ec.europa.eu/growth/sectors/medical-devices_en
• Legally non-binding guidance documents, adopted by the Medical Device Coordination Group (MDCG): https://ec.europa.eu/growth/sectors/medical-devices/guidance_en
• UK general information: https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety
• UK help desks: https://www.gov.uk/guidance/contact-mhra
• Medical Devices: VegaVend