Netherlands Medical Device Registration

Understanding Medical Device Registration and Post Market Surveillance in Netherlands

Regulatory Authority

Health And Youth Care Inspectorate

The Ministry of Health, Welfare and Sport in the Netherlands aims to improve the health and quality of life for all citizens through quality, affordable, and sustainable healthcare, prevention, healthy nutrition, and sports facilities.

The ministry encourages healthy behaviors, ensures access to healthcare providers, and works with health insurers and patient organizations to ensure adequate facilities.

Additionally, the ministry works with other ministries to provide a robust social infrastructure, including volunteer work and youth care, to ensure equal participation in society.

Link for Regulatory Authority

https://english.igj.nl/

Local Regulation

• Law on Medical Devices (15 Jan. 1970)
• Decision on Medical Devices
• Decision on in vitro diagnostics
• EU MDR

Official Languages

Dutch

Classification of Medical Devices

Class I, IIa, IIb and III

Listing or Registration Requirements

• A manufacturer or a European authorized representative established within the Netherlands and place a class I medical device custom-made medical device an assembler established within the Netherlands and place a system or treatment package Active Implantable Medical Devices IVD on the European Market.
• Sterile medical devices class I and medical devices class I with a measurement function to market the medical devices in the Netherlands, manufacturers are required to perform a CE certification conformity assessment, prepare a technical file, and draw up the conformity declaration. In addition, they must apply for CE marking for the product, as per the EU rules and regulations. They can apply for approval either through registration or notification based on the classification.
• Decoding Regulatory information pertaining to device registration or notification through Notis online registration system can prove challenging without an expert’s assistance. Moreover, given the specialized instructions in place for different classes, identifying the right class of device is crucial in determining the Regulatory pathway. 

Documents Required

Declaration of Conformity, which is issued by manufacturers of class I medical devices or IVD’s and, in case applicable, the CE certificate.

Registration Timeline

The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

License Validity

5 Years

Special Labelling Requirements

The information on labels and instructions for use must be in Dutch

Post-Market Surveillance (PMS)

Post-market surveillance (PMS) is a collection of activities which the manufacturer must carry out to monitor the safety and performance of its product once it has been launched onto the market. The aim is for the manufacturer always to have up-to-date information to provide a basis for improving the product or its safe usage wherever necessary.

It is essential that manufacturers carry out PMS to guarantee the quality and safety of medical devices and IVDs. The PMS requirement has been fleshed out in detail in European legislation. The manufacturer is obliged to verify whether the performance of the device meets the requirements for quality and performance, in other words, whether the product does what it has been made for and can be safely used.

The experiences of care professionals and/or patients with using the device can provide a basis for further investigation by the manufacturer. This may mean that the manufacturer then needs to take necessary corrective or preventive measures.

Vigilance – Reporting serious incidents and corrective actions

Manufacturers and authorized representatives of medical devices and IVDs are legally obligated to report serious incidents in the Netherlands to the Inspectorate, as well as any corrective measures related to safety, such as temporary product recalls.

You should use this MIR form to report incidents to us until EUDAMED is fully functional, the following rules then apply:

• Fill in the incident form and send it to us by clicking the ‘Submit XML by Email’ button and attaching the entire form as a PDF file.
• You can also add other attachments which are relevant to this incident.
• You should send your email to [email protected] and in the subject line you should state ‘Your reference number: [your reference number] | Our reference number: [our reference number]’

Reporting a Corrective Action

If you rectify a defect or fault with one of your products, you must report this to the Inspectorate. Examples include:

• general recalls
• changes to the design
• changes to the instructions for use
• changes to your product’s packaging

For automatization purposes we ask you to supply the information to the Inspectorate in the following format. Please fill in the digital form and save it

Timeframe for Reporting

The Inspectorate will confirm receipt of your report in writing. The Inspectorate will assess:

• the extent to which the incident constitutes a risk to patient safety.
• whether the corrective action sufficiently reduces the chance of the incident reoccurring.
• whether further research is required based on your report.

Additional Comments

The European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) replaced older Directives in 2017, with transitional periods for applying them. In the Netherlands, manufacturers, authorized representatives, assemblers, and IVD manufacturers established within the country must register certain medical devices and IVDs placed on the EU market. 

This includes Class I devices under your own name, custom-made devices, systems, or treatment packages, and all IVDs. While transitional periods existed in spring 2020 and 2022, full enforcement deadlines were May 26, 2021, for MDR and May 26, 2022, for IVDR. Remember, the correct terminology is “Regulation” not “Decree.” For detailed information, consult resources like the Dutch Health and Youth Care Inspectorate, Business.gov.nl, and CIBG Farmatec.

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]