Medical Devices Regulation in the Netherlands by Farmatec

1. Overview

Farmatec, part of the Dutch Ministry of Health, Welfare and Sport, handles administrative tasks related to medical devices (MD) and in vitro diagnostic medical devices (IVD) in the Netherlands. It manages notifications for manufacturers and authorized representatives, as well as requests for free sales certificates (export declarations). The regulatory framework is based on European Regulations MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), which have replaced the previous Directives. Source: https://english.farmatec.nl/medical-devices

2. Risk Classifications

Medical devices and IVDs are classified into risk classes as defined by law:

• Under the old MDD (Medical Devices Directive): Classes I, IIa, IIb, III.
• Under IVDD (In Vitro Diagnostic Directive): IVD other, IVD self-test, List B, List A.
• Under MDR: Classes I, Is (sterile), Im (measuring), Ir (reusable surgical instruments), IIa, IIb, III.
• Under IVDR: Classes A, B, C, D.

These classifications determine the level of regulatory scrutiny required. Source: https://english.farmatec.nl/medical-devices

3. Transition to New Regulations

The MDR fully applies to all medical devices placed on the European market from 26 May 2021, including those already on the market, with transitional provisions under Regulation (EU) 2023/607 providing extra time in specific cases. Similarly, the IVDR applies from 26 May 2022, with transitional provisions under Regulation (EU) 2022/112. These changes affect existing registrations and require compliance updates. Source: https://english.farmatec.nl/medical-devices

4. Notifications

Dutch manufacturers and Netherlands-based authorized representatives of non-EU manufacturers must submit notifications for medical devices and IVDs in specific risk classes. Notifications are submitted online via the NOTIS system, requiring a Level 2+ eRecognition token for login. The IVDR's entry into force impacts the process for existing notifications. Farmatec provides guidance on obtaining eRecognition and a step-by-step plan for submissions. Source: https://english.farmatec.nl/medical-devices

5. Export Declarations

Farmatec issues free sales certificates for devices that can be freely traded on the EU market. Requests are submitted online via NOTIS, similar to notifications. The IVDR affects existing export declarations as well. Source: https://english.farmatec.nl/medical-devices

6. Placing on the Market

All medical devices must comply with the MDR to be placed on the European market from 26 May 2021. All IVDs must comply with the IVDR from 26 May 2022. This ensures safety, performance, and conformity with EU standards. Source: https://english.farmatec.nl/medical-devices

7. Conformity Assessment and CE Marking

While not explicitly detailed, the risk classes imply conformity assessment procedures, often involving Notified Bodies for higher-risk devices. Compliance leads to CE marking, allowing market access across the EU. Manufacturers must ensure devices meet essential requirements. Source: https://english.farmatec.nl/medical-devices

8. Requirements for Manufacturers and Importers

Dutch manufacturers and authorized representatives need to be registered in the Commercial Register with an establishment number. Notifications include required documents submitted online. Non-EU manufacturers appoint an EU-based representative for compliance. Source: https://english.farmatec.nl/medical-devices

9. Supervision and Additional Information

Farmatec focuses on administrative roles, while broader supervision falls under health authorities. For more details, contact Farmatec or refer to linked pages on notifications and export declarations. Source: https://english.farmatec.nl/medical-devices