In this article, we’re diving into the world of the UK MDR 2002 device classification system. We want to break down the jargon, highlight the important parts, and show you why it matters for everyone involved – from the people manufacturing the devices to those using them.
The Medical Device Regulations 2002 (MDR 2002) are the primary piece of legislation governing the placing on the market and use of medical devices in the UK. Originally implemented in 2002 to transpose the European medical device directives into UK law, it covers all types of medical devices, from simple bandages to complex implantable devices.
The EU Directives transposed into the MDR 2002 are:
- Active Implantable Medical Device Directive 90/385/EEC (AIMDD).
- Medical Device Directive 93/42/EEC (MDD).
- In-Vitro Diagnostic Directive 98/79/EC (IVDD).
Following the UK’s departure from the EU, several amendments were released to reflect this new regulatory landscape. We consider these changes to be a band-aid to major gaps which formed due to Brexit and would anticipate new UK legislation in the future.
Under the UK MDR, medical devices must be placed into specific risk classes which will determine any additional requirements to be met by that particular product. Accurate device classification holds paramount importance as it serves as a cornerstone for patient safety, aligning regulatory measures with the varying risks associated with distinct medical devices. This precision not only safeguards against the introduction of unsafe products but also ensures an efficient regulatory process.
Understanding Medical Devices #
The first step is to make sure your product qualifies as a medical device as defined by the UK MDR 2002:
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.
Any product meeting the above definition shall qualify as a medical device and would need to meet the requirements of the UK MDR 2002.
We recommend that you start by putting together a very clear intended purpose for your product including any indications, contraindications, environment of use, users and patient populations, as well as a mode of action. Having a well-stated intended purpose will allow you to accurately verify whether your product is a medical device and it will assist in the subsequent stages.
As you can see, the definition of a medical device captures a vast number of products! These include:
- Wheelchairs, walking aids, hospital beds.
- Syringes, tubing, organ containers, blood bags.
- Bandaids, bandages, wound dressings.
- IVF products.
- Dentistry products including mirrors, dental fillings, implants, trays.
- Gloves, surgical masks, drapes, instrument covers.
- Endoscopes, hearing aids.
- Needles, scalpels, sutures, guidewires, drill bits.
- Catheters, stents, heart valves, cannulas.
- Hip implants, breast implants, spinal disc replacements.
- Ultrasound transducers, MRI, CT, X-Ray diagnostics, PET, gamma cameras.
- Lung ventilators, brachytherapy.
- Software including computer aided diagnostics, physiological monitoring applications, conception support, certain digital healthcare apps.
And so much more!
UK Medical Device Classification Categories #
To determine which requirements each device must meet, the next step will be the classification stage in which the devices are given a distinct risk-based class. In the UK, a medical device may fall into one of the following classifications, in order of increasing risk:
- Class I.
- Class IIa.
- Class IIb.
- Class III.
The Class I category may be further broken down into additional sub-categories if the product is provided in a sterile state or has a defined measuring function.
Here are some examples of devices for each risk class:
Syringe with no needle.
Mechanical barrier wound dressings.
Dental aspirator tips.
|Dressings for severe burns.
Hip, knee, shoulder joint replacements.
Criteria for UK Medical Device Classification #
The device classification is determined by following the Rules in Annex IX of EU MDD. Each classification rule describes a type or types of devices. For example, Rule 5 states:
All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:
- are in Class I if they are intended for transient use,
- are in Class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class I,
- are in Class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in Class IIa.
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class IIa or a higher class, are in Class IIa.
As you’ll note, the Rule doesn’t mention a specific device but it intends to capture a type of device which has the above features. The purpose of these rules is to assess the risk class of devices systematically.
In this step, you would be expected to go through each Rule and determine whether it applies to your device, or not. We recommend recording your rationale as to why each Rule may or may not apply to your product.
You may find multiple rules which apply to your product in which case you should choose the highest resultant risk classification.
Conformity Assessment and Compliance #
You have successfully classified your medical device! Now it’s time to determine which additional requirements your product must comply with.
Article 11 of the EU MDD describes the conformity assessment procedures for the different risk classifications. Each paragraph specifies which Annex of the Directive and which additional specifications must be met for each classification.
So, for a Class III device (Article 11(1)):
In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:
- (a) follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); or
- (b) follow the procedure relating to the EC type-examination set out in Annex III, coupled with:
- (i) the procedure relating to the EC verification set out in Annex IV; or
- (ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance).
This means that a manufacturer of a Class III medical device must follow either Annex II or Annex III coupled with Annex IV or Annex V.
You would then go to those particular Annexes and ensure your technical documentation and Quality Management System meet those requirements.
When it comes to Class I products the process to market is simpler. In a nutshell, manufacturers must draft up the required technical documentation, register their devices on the UK market, and begin to sell.
On the other hand, higher-risk devices must undergo a formal assessment by a UK Conformity Assessment Body, or CAB. This means that there is a layer of scrutiny on the manufacturer’s quality management system and documentation prepared by a third-party organisation. In theory, this ensures that riskier products are manufactured to a high level of quality, safe, and efficacious.
So before placing a product on the UK market, Class IIa, IIb, and III device manufacturers (as well as Class I devices with a sterile or measuring aspect) must apply for an assessment by a Conformity Assessment Body. Once approved, the manufacturer will be awarded a UKCA Certificate for that product portfolio and can start selling on the UK market.
How Can We Help? #
At this point, you might be thinking:
- We don’t have the resources or knowledge to take this on! or,
- This is going to take too long! or,
- This is way too complicated.
This is where we come in.
We would be able to prepare your technical documentation, assist in submitting to a CAB and maintain your place on the UK market.
Contact us to find out more.
Active Implantable Medical Devices #
In the UK MDR 2002, Active Implantable Medical Devices (AIMDs) are considered somewhat separately and must be compliant with the EU’s AIMD Directive 90/385/EEC. An AIMD is defined as a medical device which:
- (a) relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; and
- (b) is intended to be totally or partially introduced into the human body (whether surgically or medically, including being introduced into a natural orifice) and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced,
even if it is intended to administer a medicinal product or incorporates as an integral part a substance which, if used separately, would be a medicinal product;
Examples of AIMD include implantable pacemakers, cochlear implants, implantable nerve stimulators, and implantable infusion pumps.
AIMDs do not have a specific classification assigned to them; they would just be referred to as an Active Implantable Medical Device. With that said, their conformity assessment would be similar to that of a Class III medical device and would typically require an examination of the design dossier.
Following the procedures either in Annex 2 or Annex 3 + (Annex 4 or Annex 5) of the AIMDD 90/385/EEC, a successful assessment by your CAB will grant you the UKCA and allow you to place your product on the UK market.
In-Vitro Diagnostic Devices (IVDs) #
In the UK MDR 2002, an In-Vitro Diagnostic (IVD) device is defined as:
a medical device which—
- (a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and
- (b) is intended by the manufacturer to be usedin vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information—
- (i) concerning a physiological or pathological state,
- (ii) concerning a congenital abnormality,
- (iii) to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or
- (iv) to monitor therapeutic measures,
and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used forin vitro diagnostic examination;
IVDs under the UK MDR 2002 do not enjoy a well-defined classification system.
Under the EU’s now-obsolete IVD Directive 98/79/EC (IVDD), products were either categorised as falling under List A or List B of Annex II, self-test devices, or General IVDs.
The vast majority of IVDs are categorised as General IVDs since the device types listed under List A and B of Annex II are limited. In terms of requirements, General IVDs are similar to Class I medical devices in that they do not require third-party conformity assessment procedures by CABs prior to affixing the UKCA mark.
On the other hand, IVDs falling under List A or B of Annex II, and devices considered as self-test IVDs will need to submit an application for a CAB assessment.
Regulatory Changes and Updates #
The UK MDR 2002 saw major changes in 2020 as the UK formally left the EU. Since this was done before the application date of the EU medical device regulations, the UK continued using the previous EU directives.
Since then, whilst there have been changes to the UK MDR 2002, the classification system has not been impacted. Whilst there are plans in place for a total upheaval of UK regulations on medical devices, these have been hit by delays and unfortunately little is known of their status and timelines.
For more information on this subject, check out our other relevant articles:
Navigating Borderline Products #
In some cases, it may be difficult to determine exactly which side of the fence a device properly belongs to. It may be either a medical device, a cosmetic, a medicinal product, a biocide, a consumer product, or a food supplement. These products can be difficult to classify because they may have characteristics of both medical devices and other products.
We suggest starting with the intended purpose of your product and making sure you understand how the product works (even on a cellular level, when applicable). By then taking a look at the definitions, you should be able to correctly qualify your product as a medical device or otherwise.