Registration and deregistration of medical devices or IVD's
A manufacturer may place a medical device or in vitro diagnostic product (IVD) on the European market in case it observes all relevant legislation. The Health and Youth Care Inspectorate has the responsibility to supervise that it observe all relevant legislation. Proper registration of a device at the competent authorities is one of the legal obligations and helps the Inspectorate to maintain supervision.
Hereafter you will find more information about the obligation for manufacturers and European authorised representatives concerning registration and deregistration of their medical devices or IVD's. The information is mainly addressed to companies and persons who introduce medical devices or IVD into the European market.
When to register a medical device or IVD?
Some medical devices, including class I medical devices, and all IVD's must be registered. In the cases below (see summary), you are legally obliged to make this registration You make this registration at Farmatec by the Notis online registration system. Farmatec is part of CIBG (Central Information Unit on Health Care Professions) and performs all administrative procedures concerning these registrations.
When you register a medical device or IVD for the first time, you have to register details such as the name and full address of your company. Farmatec will also ask you to submit the Declaration of Conformity, which is issued by manufacturers of class I medical devices or IVD's and, in case applicable, the CE certificate.
In the Netherlands, you are legally obliged to register medical devices or IVD's if you are:
- a manufacturer or a European authorised representative established within the Netherlands and place a class I medical device supplied under your own name on the European Market (Article 5 (1) of the Medical Devices Decree);
- a manufacturer or European authorised representative established within the Netherlands and place of a custom-made medical device on to the European market (Article 5 (2) and Article 12 of the Medical Devices Decree);
- an assembler established within the Netherlands and place a system or treatment package on the European market (Article 5 (2) and Article 10 of the Medical Devices Decree and Article 5a (1) of the Active Implantable Medical Devices Decree);
- a manufacturer or European authorised representative that places an IVD on the market within the Netherlands.
Sterile medical devices class I and medical devices class I with a measurement function must also be registered. A notified body must have assessed whether the sterile part and the measurement function of the product observe all relevant legislation. You can upload the certificate that is issued within Notis as well.
If you no longer have the registered products in stock and no longer place them on the European market, you are legally obliged to inform Farmatec.
If the data that you registered in Notis is outdated or no longer applicable, you are obliged to update your registration. This includes amendments of address details, company name, but also changes related to the products that you have registered.
Responsibility of manufacturer or European authorised representative
Farmatec will send you confirmation when the registration in Notis is completed. The confirmation is merely an administrative formality. CIBG, of which Farmatec is part, is an implementing organisation and not a supervisory body. Therefore, you are responsible for correct registration of the product and to ensure the products are correctly classified.
Registration of clinical investigation
You can inform the Inspectorate of clinical investigation with medical devices. For information related to this topic please refer the pages about clinical investigation.
Responsibilities and tasks of the Health Care Inspectorate
The Inspectorate checks whether manufacturers of medical devices and IVD's observe all relevant legislation and takes enforcement measures when breaches are committed. One of the legal requirements is the obligation of registration described above. In case of breaches, the Inspectorate is competent to impose a fine of up to €450,000. More information related to the enforcement measures that can be imposed by the inspectorate in case of breaches, you can find at the Policy Guidelines on Administrative Fines by the Minister of Health, Welfare and Sport (Dutch).