Notifications for Medical Devices in the Netherlands

1. Overview

Farmatec manages notifications for Netherlands-based manufacturers or their authorised representatives when marketing medical devices or procedure packs in specific classes, such as Class I, custom-made, and all IVD risk classes. Notifications are submitted via the NOTIS system, which requires an eRecognition token for login. Source: https://english.farmatec.nl/medical-devices/notifications

2. Who Must Submit Notifications

Notifications are required for:

• Class I medical devices
• Custom-made medical devices
• In vitro diagnostic medical devices (IVDs) in all risk classes

This applies to Dutch manufacturers and Netherlands-based authorised representatives of non-EU manufacturers. Source: https://english.farmatec.nl/medical-devices/notifications

3. Submission Process

Notifications and amendments (e.g., modifications, conversions, de-registrations, re-registrations) are handled online through NOTIS. Log in using Level 2+ eRecognition. Each product entry costs €200. Processing can take up to 90 days once all information and documents are submitted. De-registrations or modifications may take up to 3 months. Source: https://english.farmatec.nl/medical-devices/notifications

4. Required Documents

Specific documents are required for notifications, detailed on Farmatec's website. For general medical devices, refer to the documents-required page. For custom-made devices, a dedicated page lists requirements. Source: https://english.farmatec.nl/medical-devices/notifications

5. Impact of MDR and IVDR

MDR Changes

Existing MDD notifications compliant with MDR must be entered in EUDAMED or temporarily amended in NOTIS until EUDAMED is fully operational. New Class I MDR devices should preferably be registered in EUDAMED, otherwise in NOTIS. Procedure packs, Class I devices, and IVDs are encouraged to use EUDAMED. An SRN (Single Registration Number) is required for EUDAMED, obtainable via Farmatec. Source: https://english.farmatec.nl/medical-devices/notifications

IVDR Changes

Existing IVDD notifications compliant with IVDR must be entered in EUDAMED or temporarily amended in NOTIS. New IVDs (all classes) should preferably be registered in EUDAMED, otherwise in NOTIS. Source: https://english.farmatec.nl/medical-devices/notifications

6. Transitional Provisions

For MDD Legacy Devices

Class I devices under MDD that require Notified Body involvement under MDR, with a conformity declaration before 26 May 2021, can be registered in NOTIS until 31 December 2028 if they comply with MDD, have no significant modifications, implement a quality management system by 26 May 2024, submit a formal request to a Notified Body by 26 May 2024, and sign an agreement by 26 September 2024. A transitional document stating the MDR risk class is required. For devices previously registered elsewhere in the EU, adoption by a Dutch authorised representative needs a declaration and proof of prior registration. Source: https://english.farmatec.nl/medical-devices/notifications

For IVDD Legacy Devices

IVDs under IVDD requiring Notified Body under IVDR, with conformity declaration before 26 May 2022 and placed on market before that date, can be registered in NOTIS with validity until specified dates (26 May 2027 for class D, 26 May 2028 for class C, 26 May 2029 for class A sterile or B). Conditions include IVDD compliance, no significant modifications, quality management system by risk-specific dates, formal Notified Body request by dates (26 May 2025 for D, etc.), and agreement signed 4 months later. Source: https://english.farmatec.nl/medical-devices/notifications

7. Obtaining eRecognition

eRecognition is necessary for NOTIS access. Guidance on obtaining it is provided by Farmatec. Source: https://english.farmatec.nl/medical-devices/notifications

8. Additional Information

For clinical research notifications, refer to CCMO. For incident reports (MIR) or corrective actions (FSCA), contact the Health and Youth Care Inspectorate. Source: https://english.farmatec.nl/medical-devices/notifications

9. Conclusion

The notification process ensures compliance with EU regulations, facilitating market access while maintaining safety standards.