On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom. The response outlined the intended regulatory reform including the transitional arrangements for CE and UKCA marked devices placed on the Great Britain market. At the time of writing the UK Government aims to bring new medical device regulations into force by July 2024. What follows is a summary of the status of Great British regulatory environment as of January 2023.
Devices in Great Britain are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which give effect in UK law to the directives listed below:
- The Medical Devices Directive (EU MDD - 93/42/EEC),
- The Active Implantable Medical Devices Directive (EU AIMDD - 90/385/EEC)
- The In-Vitro Diagnostic Medical Devices Directive (EU IVDD - 98/79/EC)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. However, under the Northern Ireland Protocol (correct at the time of writing – February 2023) different rules apply in Northern Ireland to those in the rest of the United Kingdom (Great Britain). The directives listed above together cover all medical equipment being placed on the market in Great Britain (England, Wales & Scotland). For more information on the regulatory system for medical devices outside of Great Britain please see our EU MDR and Northern Ireland pages.
Note that if you are importing OEM devices from outside of the UK to sell under your own brand within the UK, you are classed as a manufacturer and the same obligations apply to your device as to other UK-manufactured devices and you may not be able to rely on the markings associated with an OEM device. See our page for Importing CE marked Medical Devices into the UK.
The Medical Devices Directive (EU MDD – 93/42/EEC)
The MDD has a very wide scope and it is important to realize that the intended purpose and claims made in the marketing of a product can cause it to be covered or excluded. The scope includes equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. The Directive excludes any products which come within the scope of either the EU AIMDD or EU IVDD.
The Medical Devices Directive provides a harmonised regulatory environment for all medical devices sold within Great Britain. All products which fall within the scope of the Directive must meet certain essential safety and administrative requirements and are to be UKCA marked to show that they comply. Such products may then be freely sold throughout Great Britain.
The MDD defines a medical device as:
“any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which -
(a) is intended by the manufacturer to be used for human beings for the purpose of-
i. diagnosis, prevention, monitoring, treatment or alleviation of disease,
ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
iii. investigation, replacement or modification of the anatomy or of a physiological process, or
iv. control of conception; and
(b) 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, and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.
Devices for Special Purposes
Custom-made devices and those intended exclusively for the purposes of clinical trials are excluded from certain of the Directive's administrative provisions, although they must still meet the essential safety requirements and may only be applied to patients by clinical specialists.
Excluded from the provisions of the MDD are medical products which fall within the scope of the AIMDD and the IVDD although clearly, they are subjected to equally stringent controls under other directives or national legislation.
Medicinal products, cosmetics, human blood products and transplant tissue are also excluded, but covered by other Directives.
Due to the wide scope of the MDD, there is potential overlap with other Directives. However, the MDD includes provisions for all relevant hazards, including mechanical and electrical safety and provisions for electromagnetic compatibility. Devices which fall within the scope of the MDD are generally excluded from the scope of the other Directives. However, equipment that may have an application which is not exclusively medical will usually have to comply with the other Directives in addition to the MDD.
It is also important to realise that some equipment may fall into or out of the scope of the MDD solely on the basis of the purpose to which the equipment is intended to be put and the way it is marketed. If the manufacturer makes any claims that the equipment has therapeutic effects or alleviates the symptoms of any disability, injury or illness, the equipment is within the scope of the MDD and (at the very least) product registration and appropriate documentation are required.
Examples of products which are considered to be medical devices include:
- Medicine measuring cups
- Dental instruments
- Prescription spectacles and contact lenses
- Bandages and splints
- Dental treatment chairs
- First aid kits
Equipment which (in the UK at least) is not considered to fall within the scope of the MDD includes:
- Baby nappies
- Intense Pulsed Light (IPL) therapy for, for example, hair removal
- Sunglasses (which are covered under the Protective Personal Equipment Directive)
- “Consumer products aimed at comfort”
- “Products for sport or leisure”
- Cosmetic products, including tooth whitening products
An example of equipment which may or may not be within the scope of the MDD depending on the purpose for which they are marketed are protective gloves - those intended for use in direct contact with patients will be considered as medical devices while those used (for instance) in a medical laboratory are considered to be PPE.
The Directive applies different administrative requirements to devices depending on the risk which they present to the user. There are four classifications:
- Class I - generally regarded as low risk
- Class IIa - generally regarded as medium risk
- Class IIb - generally regarded as medium risk
- Class III - generally regarded as high risk
Once it has been decided that a device falls within the scope of the Medical Devices Directive, the actual device classification is determined by a series of rules which are laid out in Annex IX to the MDD. Essentially these start by saying that anything which is not covered by one of the other rules is a class I device, and then go on to give more detailed rules for the classification of other equipment. Typical factors upon which the rules decide are whether the device is intended for long term or short-term use, whether it involves the use of associated pharmaceuticals and chemicals, whether it is invasive in normal bodily orifices or via surgical insertion, and whether it operates by the exchange of energy with the body. Definitions of terms used to describe these factors are also included in the Annex.
Caution: This is not an exhaustive list of the factors covered in the rules; these rules are complex and should be considered carefully in the light of each specific application.
Registration of Devices
For Class I devices, custom made devices, devices for clinical investigation and procedure packs the Manufacturer must be registered with the Medicines and Healthcare Regulatory Agency (MHRA) who are the UK’s Competent Authority. The MHRA will only register manufacturers who are resident in the UK so if the manufacturer is not based within the UK, then they must appoint someone to act as their Responsible Person and their name and address must appear on the product.
Annex I of the MDD details a series of essential requirements for the design of medical devices. The Essential Requirements apply to all medical devices and include:
- a general requirement for safe design
- the minimisation of risks from contamination
- compatibility with materials with which they are likely to come into contact
- the minimisation of hazards of infection and microbial contamination
- provision of sufficient accuracy (for devices with a measuring function)
- protection against radiation
- adequate product marking
- adequate user instructions
The details of these essential requirements are laid out in a series of standards which have been (or are being) developed to meet the requirements of the Directive.
In addition to Registration, manufacturers (or their agents) must typically:
- comply with the essential requirements of Annex 1 of the Directive
- demonstrate design verification
- carry out a risk assessment
- demonstrate clinical evidence of the effectiveness of the device
- implement a procedure for post market surveillance
- complete a Declaration of Conformity
- maintain a file of technical information about the product
- Put the UKCA mark on the product (or its packaging)
The different classifications of medical device are subject to different conformity regimes, as follows:
- CLASS I devices are subject only to the requirements laid out above, (except for sterile products and measuring devices which are also subjected to a limited degree of notified body intervention relating to those aspects of the device affecting the sterility or the measuring function. Intervention is likely to consist of a type approval and the audit of a quality systems and manufacturing processes.)
- CLASS IIA devices are subject to all the requirements for Class I devices, and additionally the manufacturer is required to undergo an audit of their production quality assurance scheme by a notified body. This does not necessarily require a fully integrated ISO 13485 Quality Management System (QMS) but without this, a type approval of the product would be required instead.
- CLASS IIb devices are subject to all the requirements for Class I devices, and in addition the manufacturer is required to maintain a full quality assurance system covering all aspects of production from design through to final examination and testing. For practical purposes this means compliance with EN ISO 13485. In most cases, type approval of the product by a notified body is an integral part of the quality system registration.
- CLASS III devices are subject to the same requirements as Class IIb devices but additionally the manufacturer must submit a design dossier to a notified body for approval.
Post-Market Surveillance and Vigilance
One of the other provisions which distinguishes the Medical Device Directives from the other New Approach Directives is that they establish standing committees to consider the development and application of standards produced in support of the essential requirements, and to consider (in effect) 'matters arising' regarding the safety of devices within the scope of the Directives.
As part of this process of consideration, the requirement for a formal vigilance procedure is established by the Directive, through which manufacturers, their Authorised Representatives, health professionals and others must have a plan for obtaining information on the performance of devices in the marketplace and report certain problems which arise in the use of medical devices and in clinical trials. This vigilance system is administered by the MHRA in the UK, and requires each manufacturer to have a procedure in place for post market surveillance and reporting of adverse incidents.
As with all CE marking directives, the actual requirements for any piece of equipment under the directive are complex and dependent on not only the design but also the type of user, the intended use and sometimes even what is claimed in the instructions or sales literature.
For further advice specific to your products, please contact us at Conformance and we will be pleased to discuss your needs.