Do you use or manufacture medical devices? To introduce a medical device onto the European market it must comply with 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 instance:
- breast implants
- surgical instruments
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 a medical device.
In vitro diagnostics
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)
- IIa medical devices with moderate risk (such as hypodermic needles)
- 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 XIII of the European Directive on medical devices.
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. You must notify the Health and Youth Inspectorate (IGJ) of clinical research.
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. 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.
Registering medical devices
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). From 26 May 2021 you need to register data on your company and yourself.
After registration you will get a Single Registration Number (SRN). You need this number to apply for an assessment of your medical device with a notified body. This applies to all classes of medical devices. You can check the European Commission’s guide to using EUDAMED (pdf) for more information on registering.
Please note: EUDAMED is still under development. The EUDAMED module for registration of medical devices is not available yet. You have 18 months to register your medical devices from the moment EUDAMED is fully operational.
Notifying medical devices
Some medical devices, for instance those devices 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 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 possible, a manufacturer should also present the information in symbols. If you are certain your medical devices and IVDs will only be used by healthcare professionals with a good command of 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.
Reporting incidents and changes
As the manufacturer or representative you remain responsible for your product. You must keep track of it and if necessary improve it. 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 are obliged to 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).