In this instalment of In conversation with, we chat to Bryan Lister, our senior regulatory affairs consultant specialising in medical and IVD devices. We go back to basics, and define what medical devices are, and how we ensure that they’re safe for public use.
To get us started, let’s start with the basics. What are “medical devices”
Medical devices come in all shapes and sizes – there is incredible diversity across the spectrum. In fact, there are more than half a million different medical devices on the market in Europe in a range of sizes – including devices sold and used by the thousand, and products where a company might sell less than ten a year.
For example, anything from a disposable sterile tongue depressor that costs just a few pence/cents, up to hospital scanner or surgical robots that cost nearly £2m each.
Devices can be used on the body, in the body, or near the body. Examples include wearables such as an insulin pump, implanted products such as hip and knee replacements and pacemakers, or even an app or website that is based around software and not physical at all.
Some devices may also be combined with medicines, for example a cannula that is heparinised to prevent blood coagulation, and some are reused time and again after sterilisation, such as a medical endoscope.
And sometimes, it can be really tricky to understand if a product is considered a medical device or not — it’s not uncommon to have a product that is borderline and needs some deeper investigation
How then can you define what a medical device is?
Broadly speaking, the main objective of any medical device is that it helps people and their health. We want products to be safe, incur minimal risk, and to be effective in what they do.
Sadly, that has not always been the case and historically some products have been brought to the market that have been problematic, such as breast implants and hips that have failed. So, just like pharmaceuticals, medical devices have become increasingly regulated, and if we look into the regulations, they provide the definitions we need.
In Europe, from 2017, we have had REGULATION (EU) 2017/745 that entered force, that most people simply now call “the MDR” — i.e. the Medical Device Regulation.
If we look at medical devices through the eyes of the MDR, it’s really helpful because it provides us with definitions and then rules about deciding if something is a medical device or not, but also gives a framework regarding how to consider them further, based on their relative risks.
So firstly, let’s look at this through eyes of the MDR and how it defines ‘medical device’.
Chapter 1, article 2 of MDR gives this definition:
“A medical device means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination for human beings, for one or more of the following specific medical purposes:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability
- Investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state
Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations”
And this is a key phrase: “And which does not achieve its principle intended action by pharmacological, immunological, or metabolic means in or on the body. But which may be assisted in its function by such means.”
This is the core definition, but the regulation has to cover a lot of product diversity, so there are some exceptions.
The regulation goes on to say, “The following products shall also be deemed to be medical devices:
- Devices for the control or support of conception
- Products specifically intended for the cleaning, disinfection or sterilisation of devices”
While trying not to confuse things, the MDR also addresses a group of products that we should mention. Have you ever seen actors that are wearing contact lens that appear like the eyes of a cat, or give the appearance of a red iris? Or implants that go under the skin to give people horns or pixie ears?
While such contact lenses or implants only have an aesthetic purpose and do not address a health need, you can see that their function and risk is similar to medical devices by being worn or implanted into the body. These are considered under MDR Annex XVI as ‘products without an intended medical purpose’.
Other products such as dermal fillers, body sculpting equipment, and Intense Pulsed Light (IPL) machines for body hair removal are considered as not having ‘an intended medical purpose’ under the MDR, but are regulated by it.
This means that you can no longer go down to the local joke shop and buy some Halloween contact lenses – clearly these things are interacting with the body in some way so there is a risk and they have now been brought into MDR to ensure patient safety from unregulated products.
What does this mean in layman’s terms?
That definition has to be as long and detailed as it is, to wrap itself around and apply to a huge number of products that are regulated for quality and safety. Really, it’s the manufacturer’s responsibility to decide themselves if their product has an intended medical purpose, and as ever, often the answer is: it depends.
Let’s take an example, a simple product we are all familiar with – toothpaste.
Toothpaste used to be just sold for cleaning teeth, and was a cosmetic product similar to soap or shampoo.
Now, if you walk into a pharmacy or a supermarket etc. you can buy all sorts of different types of toothpaste, some of which are being marketed for specific health benefits. The difference between a toothpaste that simply cleans the teeth and one that relieves dentine hypersensitivity, for example, is that the latter has a medical claim and as such is evaluated independently in the EU by a Notified Body.
You might then say that the toothpaste is a medicine, but we need to consider how the product works i.e. what is its mode of action? How does it create its effect?
Toothpastes that prevent sensitivity work by containing an ingredient that physically blocks dentine tubules in the teeth. Therefore, such toothpastes are considered as medical devices because they work by physical action and are therefore not medicinal products that instead work by pharmacological, immunological, or metabolic means. However, there are some toothpastes that are medicinal products — for example if they have a very high fluoride content.
If you pick up a tube of toothpaste and want to check if it is a medical device, look on the label and see if it is CE marked (or UKCA marked).
What is the CE mark and also, what is the UKCA you referred to?
The CE logo is familiar to us all, though we may not always notice it. We can find it on the back of computers, mobile phones, TV sets, PPE such as face masks, crash helmets, safety gloves, gas cookers, and measuring equipment and many more items.
It means that the product satisfies the applicable legal requirements to be sold in the EU. It’s the same for medical devices and In Vitro Diagnostics, such as Covid self-test kits.
‘CE’ itself stands for “Conformité European”, which simply translates into English as ‘European Conformity’. It means that the product has gone through a European conformity assessment process.
For low risk products, the manufacturer can undertake that process, but for most medical devices a conformity assessment is carried independently by an appropriate Notified Body, and if it does conform, a certificate is issued. Once a manufacturer has received the certificate, they can make their declaration of conformity and can affix the CE mark to the product.
To note here, each Notified Body has an assigned number which will be displayed next to the CE Mark on a product. If no number is displayed, the CE mark has been self-certified and is therefore a Class I product, i.e. poses the lowest risk.
But what is the UKCA mark?
Before the UK’s withdrawal from the European Union, any medical device entering the UK market required CE marking. Following Brexit, the UKCA mark, or ‘UK Conformity Assessment’ mark was created as our local equivalent for marking products to demonstrate they meet our local legislation. It’s a kind of parallel system.
To read more about the difference between CE and UKCA marking, as well as when UKCA comes into effect, read our detailed blog on the subject here.
How do you make sure a device is safe?
It’s all about minimising risk. There are different risk classes which have different requirements. For example, a pacemaker and hip replacement will pose a higher risk than a tongue depressor. Therefore, we must segregate products based upon their risk.
Using MDR as an example, that provides us with a set of rules to apply that help us consistently assess what the risk class is for a medical device, and then that goes on to determine what safety testing, evidence, and level of post-marketing surveillance needs to apply.
In the UK and EU, products get split into increasing classes of risk – Class I, Class IIa, Class IIb, and Class III. There are subtle differences between the EU and UK due to differing regulations now applying in the UK. The regulation in the EU is more recent and therefore leans towards placing products in a higher risk group. This demonstrates a trend towards constantly managing risk in order to maximise patient safety.
For the sake of clarity, we will focus on EU regulation as this is the most recent.
Class I is the lowest risk category — a Class I device manufacturer can self-certify, i.e place a CE mark on it by making a declaration that they meet MDR themselves.
For all other medical device risk categories, the product will be independently assessed by a notified body, an independent organisation such as BSI or TUV.
At the top end of the spectrum are Class III devices. Some of these may be implantable, such as a pacemaker which is inserted in the body and that has a very important function to fulfil in maintaining heart rhythm, and which also contains an energy source. This class contains all the highest risk devices.
For the sake of completeness, it is worth mentioning that there are some types of Class I products that require Notified Body involvement for a critical element for that product.
- Class I S products are products which are sterile. The Notified Body is interested to see how it has been sterilised and given the assurance it will be sterile at the time of use.
- Class I M products — products that measure something — also require Notified Body involvement, by confirming that the product measures exactly as it should do and is suitably precise and accurate.
- Class I R products – R meaning reusable – contain products such as endoscopes that are used in hospitals, and after use on one patient have to be cleaned and sterilised ready for use on the next.
These are too expensive to be disposable, and therefore the manufacturer has to demonstrate to the Notified Body that there is a suitable process for reworking products between patients, to ensure the risk of transmission of disease from one patient to the other is kept to an absolute minimum.
If you recall we spoke earlier about products ‘without an intended medical purpose’ under MDR Annex XVI. For these products, the manufacturer also needs to identify and justify which risk class these products fall into and if necessary, pass a conformity assessment undertaken by a Notified Body.
What happens after a medical device is placed on the market?
This a large topic, as there can be a lot to consider after a product is placed on the market, and the MDR especially places more emphasis on planning for the post-market vigilance of medical devices. Remember, as much as products are tested before they go onto the market to reduce risk, the volume of product in real world use can be many orders of magnitude higher.
Naturally, all manufacturers of a device on the market must report any serious incident and any field safety corrective actions related to these devices. But let’s quickly mention the kind of plans and reporting requirements that a manufacturer should have in place.
Firstly, the Post-Market Surveillance (PMS) plan presents the processes and activities that will be conducted to monitor the device’s safety once on the market.
There is also the Post-Market Clinical Follow-up (PMCF) plan. Under the MDR, a plan is required for all devices, to specify the methods and procedures the manufacturer will use to gather and evaluate clinical data for their devices.
Finally, we have the Periodic Safety update (PSRU). For the highest risk class products, that’s Class IIb and III a report is submitted annually to the Notified Body, and every two years for Class IIa devices. This is a summary report collecting results and conclusions from post market surveillance data evaluation, including detailing and justifying any corrective and preventative actions taken.
For the lowest risk devices in Class I, a PMS report should be updated as needed, but must be available to be presented to regulators if requested.
Thank you for sharing your insight Bryan! Keep your eyes peeled for our next instalment of In conversation with appearing on our blog soon.
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