Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
February 4, 2026
Approximately 5 minutes
Required Documents for Medical Device Notifications and Exports in the Netherlands
Required Documents for Medical Device Notifications and Exports in the Netherlands
1. Overview
Farmatec, under the CIBG, specifies the documents required for notifications and export declarations (free sales certificates) for medical devices (MD) and in vitro diagnostic medical devices (IVD) in the Netherlands. These requirements ensure compliance with EU regulations, including transitional provisions from the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Documents must be uploaded with requests, and incomplete submissions are not processed. Source: https://english.farmatec.nl/medical-devices/documents-required
2. General Requirements for Documents
- Declaration of Conformity (DoC): Includes name and address of the manufacturer; legislation/regulation complied with; date of issue and signature of a competent person; product identification; authorised representative's name and address if applicable; production sites if applicable.
- CE Certificate: Includes name and address of the manufacturer; legislation/regulation complied with; date of issue and signature of a competent person; product identification; production sites if applicable. Issued by a notified body.
- Product Information: Required for new notifications under IVDR and MDR.
- Manufacturer's Declaration: Confirms no significant modifications to the device; formats available on websites of Trade Associations like AESGP, COCIR, EuromContact, MedTech Europe.
- Notified Body Confirmation Letter: Signed agreement for MDR/IVDR certification; format available at the EU Commission's website.
- Appendix for Product List/Production Site: Separate document (max 15 A4 pages, Verdana font size 9, 4 cm top margin, plain Word); uploaded as draft with specific subject; separate request to add as appendix. Source: https://english.farmatec.nl/medical-devices/documents-required
3. Who Needs to Submit
Manufacturers or authorised representatives submitting notifications or export declarations. For legacy devices registered in another EU Member State: Provide declaration of adoption by a Netherlands-registered European authorised representative and proof of prior registration. Source: https://english.farmatec.nl/medical-devices/documents-required
4. Documents for MDD/MDR (Medical Devices)
Legacy MDD Notifications (Pre-26 May 2021, Transitional to MDR)
- DoC indicating compliance with MDD and placed on market before 26 May 2021.
- Manufacturer's Declaration of no significant modifications.
- Notified Body confirmation letter for signed agreement on MDR certification.
- Applicable to devices compliant with MDD and upclassified under MDR (Article 120(3) MDR). Source: https://english.farmatec.nl/medical-devices/documents-required
New MDR Notifications
- Product information.
- DoC with MDR.
- CE certificate if applicable for MDR conformity (Class I sterile (Is), measuring function (Im), reusable (Ir)). Source: https://english.farmatec.nl/medical-devices/documents-required
MDD Export Declarations (Extended Transition Period)
- DoC to MDD.
- CE certificate if applicable for MDD conformity (Class Is/Im/Ir, IIa, IIb, III).
- Manufacturer's Declaration of no significant modifications.
- Notified Body confirmation letter for agreement by 26 September 2024 on MDR certification. Source: https://english.farmatec.nl/medical-devices/documents-required
MDR Export Declarations
- DoC with MDR.
- CE certificate if applicable for MDR conformity (Class Is, Im, Ir, IIa, IIb, III). Source: https://english.farmatec.nl/medical-devices/documents-required
5. Documents for IVDD/IVDR (In Vitro Diagnostics)
Legacy IVDD Notifications
- DoC indicating compliance with IVDD and placed on market prior to 26 May 2022.
- Manufacturer's Declaration of no significant modifications.
- Signed agreement for IVDR certification. Source: https://english.farmatec.nl/medical-devices/documents-required
New IVDR Notifications
- Product information.
- DoC.
- CE certificate if applicable for IVDR conformity (Class B, C, D); per Article 48(10) IVDR. Source: https://english.farmatec.nl/medical-devices/documents-required
IVDD Export Declarations (Extended Transition Period)
- DoC.
- CE certificate if applicable for IVDD conformity (self-test, list A, list B).
- For transitional IVDs: EU DoC before 26 May 2022.
- Manufacturer's Declaration of no significant modifications.
- Signed agreement for IVDR certification. Source: https://english.farmatec.nl/medical-devices/documents-required
IVDD Export Declarations (Without Extended Transition)
- DoC.
- CE certificate if applicable for IVDD conformity (self-test, list A, list B).
- For transitional IVDs: EU DoC before 26 May 2022. Source: https://english.farmatec.nl/medical-devices/documents-required
IVDR Export Declarations
- DoC with IVDR.
- CE certificate if applicable for IVDR conformity (Class B, C, D); per Article 48(10) IVDR. Source: https://english.farmatec.nl/medical-devices/documents-required
6. Specific Categories
- Class I MD (MDR): CE certificate if sterile (Is), measuring (Im), or reusable (Ir).
- Custom-Made MD: Follows general MDD/MDR requirements for legacy or new.
- IVD (General): Differentiated by class (e.g., B, C, D for IVDR) or lists (A, B, self-test for IVDD). Source: https://english.farmatec.nl/medical-devices/documents-required
7. Checklists or Forms
No specific checklists; formats for Manufacturer's Declaration and Notified Body confirmation letter via Trade Associations and EU documents. References to MDR Article 52(7) for CE content; IVDR Article 48(10) for CE content. Additional resources: Links to EUR-Lex for MDR, IVDR, and transitional provisions. Source: https://english.farmatec.nl/medical-devices/documents-required
8. Impacts from MDR and IVDR
Transitional provisions for legacy MDD/IVDD devices with extended periods requiring no significant changes and certification agreements. Upclassification under MDR/IVDR. References to Regulation (EU) 2023/607 for MDR and (EU) 2022/112 for IVDR transitional provisions. Source: https://english.farmatec.nl/medical-devices/documents-required
9. Conclusion
These document requirements ensure proper compliance for notifications and exports, facilitating market access while adhering to EU standards.
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Medical Devices Regulation in the Netherlands by Farmatec
Farmatec oversees notifications and export declarations for medical devices and IVDs in the Netherlands, ensuring compliance with EU regulations like MDR and IVDR, including risk classifications and transitional provisions.
Approximately 5 minutes
Notifications for Medical Devices in the Netherlands
Farmatec handles notifications for Dutch manufacturers and authorized representatives of medical devices and IVDs in specific risk classes, using the NOTIS system, with changes due to MDR and IVDR regulations.
Approximately 5 minutes
Free Sales Certificates for Medical Devices in the Netherlands
Farmatec issues free sales certificates for exporting medical devices and IVDs from the Netherlands to non-EU countries, confirming EU market compliance under MDD, AIMDD, IVDD, MDR, and IVDR, with specific requirements and transitional provisions.
Approximately 5 minutes
Applying for EUDAMED SRN Registration in the Netherlands
Manufacturers, importers, and authorised representatives in the Netherlands must apply for an SRN via EUDAMED to comply with MDR and IVDR, involving EU login, selection of Dutch authority, and submission of registration details.
Approximately 5 minutes
Custom-Made Medical Devices in the Netherlands
Custom-made medical devices in the Netherlands are regulated under the MDR, requiring notifications for manufacturers and authorised representatives, without CE marking, and specific declarations for compliance.