Medical Devices Regulatory Services
in The Netherlands

Overview

The Netherlands is one of the major Medical Device markets in Europe accounting to 3-4 % of market share. The Health Care Inspectorate (Inspectie voor Gezondheidszorg or IGZ) of Dutch Ministry of Health is responsible for implementing the Dutch Medical Devices Act in the Netherlands.

Regulatory Authority: Health Care Inspectorate (Inspectie voor Gezondheidszorg or IGZ) of Dutch MoH

Regulation: Medical Device Regulations, 2017

Regulatory Pathway: CE marking followed by Notification

Authorized Representative: European Authorized Representative (EAR) for Non-EU manufacturers

QMS Requirement: ISO 13485:2016

Assessment of Technical Data:  Notified Body for CE marking

Validity of License: Unlimited

Submission Format: Paper

The Netherlands Medical Device Classification

Prior to marketing the Medical Devices, either Active Implantable Medical Devices (AIMD) or In-vitro Diagnostic Medical Devices (IVDDM), it is mandatory for the manufacturers to obtain CE certification in the Netherlands. In order to obtain the CE marking, the market entrant must submit the devices to compliance evaluation with the essential requirements described in the applicable European directives. These European provisions have been transposed into French law in the Public Health Code.

European Authorized Representative (EAR)

Manufacturers based outside of the European Union shall appoint a European Authorized Representative (EAR) to market the devices in any of the EU member countries. The EAR appointed shall comply with all the requirements defined in the Medical Device Regulations (EU)2017/745.

The Netherlands Medical Device Registration

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 basing 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.

Process flow

Post Approval Device Life Cycle Management

Freyr supports the foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:

• Post approval change management - modifications to existing medical device approvals such as, addition of new variants, accessories; addition of new indications of use among others
• Maintenance of ISO 13485:2016 and CE certification
• Renewal of licenses
• Liaising between Notified body and the manufacturer

To obtain a CE marking successfully, Freyr assists in adhering the conformity requirements needed. Further our experts support in device classification, technical file compilation, online registration and all other Regulatory processes so as to navigate the pathway compliantly and make a successful registration.

Summary