Many products require UKCA marking before they can be sold in the UK. UKCA marking indicates that a product has been assessed by the manufacturer and deemed to meet UK safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are marketed in the UK.UKCA marking is only obligatory for the following product groups:
- recreational craft and personal watercraft
- simple pressure vessels
- electromagnetic compatibility
- non-automatic weighing instruments
- measuring instruments
- measuring container bottles
- equipment for potentially explosive atmospheres (UKEX)
- radio equipment
- pressure equipment
- personal protective equipment (PPE)
- gas appliances
- equipment for use outdoors
- low voltage electrical equipment
Some products are covered by the UKCA marking but have some special rules. Please consult the sector specific guidance for more information. They are:
- Medical devices
- Rail interoperability
- Construction products
- Civil explosives
- Marine equipment
- Energy using products
- Transportable pressure equipment
- Hazardous substances (RoHS)
This guidance Regulating medical devices in the UK regulates the UK medical devices market.Medical device legislation that applies in Great Britain
Devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which, prior to the end of the transition period, gave effect in UK law to the directives listed below:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
This means that the Great Britain route to market and UKCA marking requirements are based on the requirements derived from the above EU legislation.Requirements for placing a device on the Great Britain market
It is a requirement of the UK MDR 2002 that the MHRA is informed before a medical device is placed on the market in Great Britain.
Registration if required to companies who sell, lease, lend or gift medical devices (not 3D resins which are raw materials for making medical devices, not medical devices):
- Class I, IIa, IIb or III devices you have manufactured
- Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name
- any system or procedure pack containing at least one medical device
- custom-made devices
- IVDs you have manufactured
- IVDs undergoing performance evaluation
Registration does apply to raw materials or ingredients, such as 3D resins, used for making medical devices, which can neither be considered borderline products, as highlighted in this guidance; Borderline products: how to tell if your product is a medical device and which risk class applies, where it is indicated the types of products which may fall into the borderline category:
- herbal medicinal products
- personal protective equipment
- machinery/laboratory equipment
- food supplements
Medical devices fall into one of three categories:
- general medical devices
- in vitro diagnostic medical devices (IVDs)
- active implantable medical devices
This guidance Custom-made devices in Great Britain applies to medical devices placed on the market in Great Britain (England, Wales and Scotland). Medical device regulation in Great Britain is defined by the UK Medical Devices Regulations 2002 as they apply in Great Britain (SI 2002 No 618, as amended) (UK MDR 2002). These guidelines aim to help manufacturers understand compliance requirements for the manufacture of custom-made active implantable medical device or custom-made medical device.
As defined by UK MDR 2002 5 (1), a custom-made device is:
- manufactured specifically in accordance with a written prescription of a registered medical practitioner, or other person authorised to write such a prescription by virtue of their professional qualification, which gives under their responsibility, specific characteristics as to its design
- intended for the sole use of a particular patient, but does not include a mass-produced product which comprises a medical device and medicinal product forming a single integral product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user.
As far as active implantable medical devices are concerned the requirement is that only a medical specialist may write the prescription. This is defined in the Regulations UK MDR 2002 as ‘a registered medical practitioner as, or is undergoing training intended to lead to qualifications, a specialist’.
A written prescription may take the form of a letter from a qualified person or a moulded impression of the shape of the required device together with the order specifying customer details, and a request to ‘make as pattern’.
It is the qualified person who is responsible for specifying the particular design characteristics of the product.
The manufacturer of a custom-made device must meet the particular requirements of the UK MDR 2002 which relate to custom-made devices. These requirements are not intended to interfere in any way with the professional and clinical responsibilities of the prescriber. The activities carried out by the healthcare professional in supplying or fitting a custom-made device (e.g. preparation, impression taking, prescribing, final fitting and any adaptation), are not considered to fall within the scope of the UK MDR 2002.
Mass-produced devices, which need to be adapted to meet the specific requirements of a healthcare professional (and which are supplied for the sole use of a particular patient), are not considered to be custom-made devices.
Custom-made devices and custom-made active implantable medical devices are not required to be UKCA marked when they are first placed on the market and/or put into service. However, they must meet the relevant provisions of the UK MDR 2002 that apply to them. In addition, manufacturers of custom-made devices do not require the intervention of a UK approved body.
The manufacturer of a custom-made device must comply with the relevant Annex of the UK MDR 2002 (as modified by Schedule 2A of the UK MDR 2002) which contains provisions relating to the drawing up of a statement containing the information detailed below and the keeping of documentation relating to the device.
If the custom-made device in question would have been classified as either a class IIa, class II(b) or class III device, within the definition of a medical device or is an active implantable medical device then that device must be accompanied by the statement referred to in:
- for medical devices: Part II of the UK MDR 2002, Annex VIII (as modified by Part II of Schedule 2A of the UK MDR 2002)
- for active implantable medical devices: Part III of the UK MDR 2002, Annex VI (as modified by Part II of Schedule 2A of the UK MDR 2002)
It should be noted that the statement does not need to be provided with a custom-made device which has been classified as class I.
It is the responsibility of the manufacturer of the device to review all the requirements of the UK MDR 2002 against their procedures. This statement must include:
- data allowing identification of the device in question, i.e. description, serial number, order number, generic name
- a statement that the device is intended for exclusive use by a particular patient, together with the name of the patient (this may be an identification number if patient confidentiality needs to be maintained, provided it can be traced through records to the named patient)
- the name of the qualified person, medical practitioner or other authorised person who made out the prescription and, where applicable, their place of work
- the particular features of the device as specified in the relevant prescription, i.e. the written prescription with its special features extracted to define the particular device
- a statement that the device in question conforms to all the relevant essential requirements and, where it does not, the grounds for believing it is safe for use
- the name and address of the manufacturer
Additionally, the medical device manufacturer must retain and, upon request, make documentation available to the Competent Authority, allowing an understanding of the design, manufacture and performances of the product -including the expected performances - so as to allow assessment of conformity with the requirements of the UK MDR 2002. The documentation for all active implantable medical devices shall be kept for a period of at least 15 years from the date of manufacture.
The ‘statement’ should be available to the named patient for whom the device has been manufactured. It is a requirement that patients are made aware that they can request a statement and the statement will need to be made available on request. Whilst the technical document issued with the device should indicate if the manufacturer operates from more than one site, this need not be included in the statement.Conclusions
UKCA marking and registration of raw materials or ingredients, such as 3D resins, used for making medical devices, is not required since the UKCA marking and registration (and certification) applies only to the manufacturers or traders of medical devices.
3D resins as supplied are not medical devices, but unsafe photoreactive liquids, which react undergoing a photochemical synthetic reaction in the printers, which are phtochemical reactors, which selectively "cure" the resins in certain zones, layer by layer or continuously, to shape "solid" 3D prints, which after postcuring and postprocessing, are placed on the market as medical devices. The safety of a medical device is responsibility of the medical device manufacturer. False and misleading UKCA marking and registration to 3D resins does not fulfil the requirements for providing any level of protection, such as health and safety in general, health and safety at the workplace, protection of consumers, protection of the environment and security.
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