Regulation
intended use require that the medical device be connected to, or have an interface with, other medical device(s), you will need to verify the design outputs meet design inputs when connected or interfaced. This demonstrates that the device is compatible with the connected or interfaced device(s).
5. Design transfer - Design transfer is the process of transitioning a medical device design from the design and development stage into manufacturing. On completion and approval of all verification and validation activities, you can move on to the design transfer stage. The design transfer should be documented in the design and development traceability matrix and meeting minutes of the design review. At this stage, design transfer documentation, such as production records, must be created and passed onto manufacturing for the purpose of releasing the device to market.
6. Control of design changes - If any changes are required to your device at any stage during the design and development process, they must be documented in accordance with your change control process and reviewed to confirm whether the changes are classed as ‘significant’ in line with any regional regulatory requirements e.g. EU MDR 2017/745. You will also need to demonstrate that you have reviewed, verified, and validated the change prior to implementation.
7. Design and development file - A design history file (DHF) is the organised documentation of all product design and development processes pertaining to your finished medical device. It must be maintained for each medical device product family and contain the documentation created during the design stages.
8. Design reviews - Design reviews, also known as ‘stage-gate meetings’, are generally used to provide assurance that the activity or design phase has been satisfactorily completed and that the next stage of design can begin. They should be held at
Class (low to high risk) Class I
Class IIa Class IIb Class III
Examples
Wheelchairs, spectacles, stethoscopes, tongue depressors Dental fillings, surgical clamps, tracheotomy tubes Condoms, lung ventilators, bone fixation plates
Pacemakers, heart valves, implanted cerebral stimulators
Source:
https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/ factsheet-medical-devices-overview
Table 2: classes of medical devices Category Definition
1. Non-invasive Devices which do not enter the body
2 Invasive
3. Surgically invasive
4. Active 5. Implantable
Devices inserted into the body’s orifices
Devices used or inserted in surgery
Devices requiring an external source of power
Examples
Plasters, walking sticks, wheelchairs, artificial kidneys (external dialysis)
Contact lenses, enemas, examination gloves
Needles, scalpels,
cardiovascular catheters X-ray equipment, ultrasound,
TENS devices
Devices implanted into the body Breast implants, orthopaedic implants, intraocular lenses
Table 1: categories of medical devices
documented intervals throughout the design process, and the minutes recorded e.g., a review is conducted to ensure that design inputs are adequate and applicable to the device before work is carried out to convert them into design outputs.
Complying with designated standards When designing your device, you have the option to follow international standards that have been designated to the UK MDR 2002. By following these standards, you are conforming with the relevant parts of the directives which are covered by these standards. These include standards such as ISO 13485,
covering quality management systems (which is a big part for implementing your design control process) as well as ISO 14971 for risk management of medical devices. There are also standards which are specific to the individual device type, where the standard is not mandatory but could be classed as state-of-the-art and you would need to explain your reasonings for not following this in an audit situation.
Certification approval or not? It is important to understand the category and classification risk of your device which will aid in the decision on whether you will require your device to go through a review by a Notified Body to allow for you to sell your product. All general medical devices placed on the UK market have both a category and a
classification. There are five categories of device, determined by their use. (See Table 1)4 There are four classes of general medical
devices, determined by the inherent risk of a device. This risk assessment includes (but is not limited to) consideration of its intended length of use, its composition and whether it is implantable or active.4
(See Table 2)
Class I devices would not need to go through a conformity assessment review by a Notified Body and you will be able to self-declare your device. It should be noted that, should a device fall under the category of class I but is sterile or has a measuring function, you would not be able to self-declare and a Notified Body will need to review the elements of the sterility or measurability of the device. For devices that are class IIa or above, a
full review of your technical documentation, including design data and Quality Management system will need to take place by a Notified Body and approved before you can place your device on the UK market. Regardless of classification, you will also
need to register your device on the MHRA portal prior to selling your device. They will need to be provided with the Declaration of Conformity, UKCA certificate issued by your Notified Body (where applicable) and you will need to appoint a UK Responsible Person should you be located outside the UK.
A robust quality management system is crucial
Implementing an ISO 13485 quality management system (QMS) is paramount for businesses operating in the medical device industry and you will certainly need this to access NHS Trusts. The standard is internationally recognised, which documents the stringent requirements for the design, development, production, and distribution of medical devices, ensuring they meet regulatory and customer requirements. One of the primary benefits of ISO 13485 is
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