Free Sales Certificates for Medical Devices in the Netherlands

1. Overview

Free sales certificates, also known as export declarations, are issued for medical devices and in vitro diagnostic devices (IVDs) when exporting to countries outside the EU. These declarations confirm that the product can be freely traded on the EU market. They are managed by Farmatec under the CIBG and are based on compliance with relevant directives or regulations, including transitional provisions from the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Source: https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices

2. Who Can Apply

Applications can be submitted by manufacturers or authorised representatives registered in the Netherlands. Compilers of systems or procedure packs (SPPP), importers, and distributors are not eligible to apply for export declarations under the MDR (Article 60) or IVDR (Article 55). For systems or procedure packs containing legacy devices, declarations can only be issued based on the MDD, AIMDD, or IVDD. For products registered in EUDAMED, confirmation of registration plus a product list as an appendix is required. Source: https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices

3. Requirements

For MDD and AIMDD Devices (Legacy Devices under MDR)

The device must comply with the MDD or AIMDD and have been placed on the market before 26 May 2021. No significant changes to the device are allowed, supported by a Manufacturer's Declaration in specified formats. A Declaration of Conformity (DoC) with the MDD or AIMDD is required. The manufacturer must implement a quality management system by 26 May 2024 per Article 10(9) MDR. A formal request for conformity assessment to a notified body must be submitted by 26 May 2024, and a written agreement signed by 26 September 2024, confirmed via a Notified Body letter. Validity is a maximum of 5 years. Applicable to legacy devices not requiring a notified body under MDD but requiring one under MDR, or those with CE certificates under MDD/AIMDD issued after 25 May 2017 and valid on 26 May 2021 but expired before 20 March 2023. Source: https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices

For MDR-Compliant Devices

Devices must be fully compliant with the MDR. Validity is a maximum of 5 years or until the expiry date on the CE certificate. Source: https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices

For IVDD Devices (Legacy Devices under IVDR)

The device must comply with the IVDD and have been placed on the market before 26 May 2022. No significant changes are allowed. A DoC with the IVDD is required. The manufacturer must implement a quality management system by 26 May 2025 per Article 10(8) IVDR. A formal request to a notified body must be submitted by class-specific dates (26 May 2025 for class D, etc.), with a confirmation letter after 4 months. If notified body involvement was required under IVDD, applications are possible until 31 December 2027. Applicable to legacy devices not requiring a notified body under IVDD but requiring one under IVDR. Source: https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices

For IVDR-Compliant Devices

Devices must be fully compliant with the IVDR. Validity is a maximum of 5 years or until the expiry date on the CE certificate. Source: https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices

4. Application Process

Submit requests online via the NOTIS system, including all required documents. Login requires a Level 2+ eRecognition token. By default, the declaration lists only the group name and brand name; additional information like product lists or production sites can be requested separately with appendices. For EUDAMED-registered products, select the appropriate class and provide registration confirmation plus a product list. Indicate compliance with specific legislation such as Directives 93/42/EEC (MDD), 90/385/EEC (AIMDD), 98/79/EC (IVDD), or Regulations (EU) 2017/745 (MDR), (EU) 2017/746 (IVDR). Source: https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices

5. Costs

Each export declaration costs €62. Administration costs are €62 per invoice, sent in the next quarter. Source: https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices

6. Documents Needed

Required documents must be uploaded with the request; incomplete submissions are not processed. Specific documents include DoC for relevant directives, Manufacturer's Declaration of no significant changes, evidence of quality management system implementation, formal request and notified body confirmation letter. For EUDAMED products: registration confirmation and product list. Detailed lists are available at the documents-required page. Source: https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices

7. Processing Time

If the application is complete with all information and documents, the export declaration is issued within 4 weeks. Source: https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices

8. Impacts from MDR and IVDR Regulations

MDR transitional periods allow declarations for legacy MDD/AIMDD devices until 31 December 2027 (for class III and certain IIb) or 31 December 2028 (for others), subject to conditions like no changes, QMS by 2024, notified body request by 2024, and agreement by September 2024. IVDR periods vary by class until 2027-2029, with similar conditions adjusted for IVDR timelines. Changes reference Regulation (EU) 2023/607 (MDR) and (EU) 2024/0021 (IVDR). Source: https://english.farmatec.nl/medical-devices/free-sales-certificates-for-medical-devices

9. Conclusion

Free sales certificates facilitate exports by confirming EU compliance, with processes adapted to new regulations to ensure continued market access.