Medical devices

Do you use or manufacture medical devices? You can only introduce a medical device onto the European market if it meets the legal requirements. Your product must be safe for patients. Therefore you will need to perform (clinical) research and your product needs CE-marking. The Health and Youth Care Inspectorate (IGJ) is the supervisory body for medical devices.

What are medical devices?

Medical devices are products used for diagnoses and treatments in the healthcare sector, or products that can help prevent or predict diseases or disorders. For example:

• surgical instruments
• breast implants
• pacemakers
• wheelchairs
• software

If you are not sure if your product is a medical device, the European Medicine Agency (EMA) provides an overview of what products are seen as medical devices.

In vitro diagnostics (IVDs)

In vitro diagnostics (IVDs) are a separate type of medical devices. They are used to examine samples from body materials, such as:

• urine tests
• pregnancy tests
• blood glucose meters

Risks of medical devices

Medical devices are classified according to risk. The more risk there is for the patient, the more strict the inspections are to assess if a medical device will be allowed onto the market. There are 4 categories:

• I medical devices with low risk (such as adhesive bandages, glasses, wheelchairs)
• IIa medical devices with moderate risk (such as dental fillings, surgical clamps)
• IIb medical devices with moderate to high risk (for instance anaesthesia machines)
• III medical devices that come into direct contact with the heart, the central circulatory system, or the central nervous system (for instance cardiac catheters and contraceptive coils)

You can check how devices are qualified in Annex VIII of the European Directive on medical devices.

The risk classes for IVDs are:

• A: low risk (such as container for specimens, prepared selective media)
• B: medium risk (for example pregnancy test, cholesterol self-test)
• C: medium to high risk (such as blood glucose self-test, genetic testing)
• D: high risk (for example Hepatitis B blood donor test, HIV diagnostic blood test)

You can check how IVDs are classified in Annex VIII of the European Directive on IVDs.

Registering medical devices in EUDAMED

As a manufacturer, authorised representative, or importer of medical devices you must register data on yourself, your company, and your medical device in EUDAMED (European Databank on Medical Devices). This should be done before marketing a medical device.

Clinical evaluation and technical file

Before you market a medical device, you need to do a medical evaluation. You perform laboratory tests on the safety of your product. In some cases you will need to conduct a clinical investigation. This is an investigation with test subjects to find out if the product is safe to use and works as intended.

CE marking

Every medical device on the European market must have CE marking. CE marking means your product complies with the legal requirements. For Class I medical devices (non-sterile and/or non-measuring) you assess if the product complies with the Medical Devices Directive yourself. If this is the case, you may put the CE marking on the product.

Medical devices Class IIa, IIb, and III must be inspected by an independent authority (Notified Body). If this authority approves the product, you will receive a CE certificate. Only then are you allowed to market the medical device.

Notifying medical devices

Some medical devices, for instance, those in risk class I and all IVDs, must be registered (notified) with Farmatec. If it is the first time you register a product, you must also register your company. If you no longer supply the product or if there is a change in the product you must notify Farmatec.

Labelling and instructions for use

You must provide for clear labelling and instructions for use for medical devices and IVDs, so the patient can use the device safely and correctly. For medical devices in risk class I or IIa an instruction for use is not necessary if the patient can safely use it without instructions.

In the Netherlands, the information on labels and instructions for use must be in Dutch. You should use language that is appropriate to the education and knowledge of the potential user. If you are certain your medical devices and IVDs will only be used by healthcare professionals who fully understand the English language, you may present the information solely in English.

The address of the manufacturer must be stated on the label. If the manufacturer is from outside the EU the address of the (authorised) representative must also be on the label, the packaging, or in the instructions for use.

Keep track of the medical device

As the manufacturer or representative you remain responsible for your product. You must keep track of it and, if necessary, improve it. You must handle complaints and reports about the product, and you must ask users for information about the product's quality and performance. This allows you to intervene faster when things go wrong and further improve the medical device. A medical device must have a unique identification code (UDI). This code makes devices easier to find if there is a problem with the product, for example.

Reporting incidents and changes

If there is an incident in which your medical device is involved you must notify the inspectorate. You must also notify the inspectorate if you correct an issue with the product, for instance, if you recall it or if you change the design or packaging.

National Implants Registry

The Dutch National Implants Registry (in Dutch) registers the implants that patients in the Netherlands have received, such as artificial hip joints, artificial cardiac pacemakers, or breast implants. The Registry has nationwide coverage and registration is mandatory. Patient information leaflets on implants are also mandatory. Doctors must record data on implants in the patient's Electronic Patient Dossier (EPD) and inform the patient. The National Implants Registry will collect this data from the hospital's EPD, making it easier to trace patients with implants. Patients can use this information to report any side-effects of implants (in Dutch).