Dutch Medical Device Regulation

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Rules for manufacturing and using medical devices

https://business.gov.nl/regulation/medical-devices/

The Dutch National Implants Registry (in Dutch) registers the implants that patients in the Netherlands have received, such as artificial hip joints, artificial cardiac pacemakers or breast implants. The Registry has nationwide coverage and registration is mandatory. Patient information leaflets on implants are a… See more

Medical devices: MDR and IVDR - Government.nl

https://business.gov.nl/sector-specific/care-and-animal-care/medicines-and-medical-technologies/medical-devices-mdr-and-ivdr/

Medical devices includes many products and services: from bandages to medical apps to pregnancy tests. The new European regulations may have serious implications for …

Registration of a medical device or IVD | Medical …

https://english.igj.nl/medical-technology/market-authorisation/registration-and-deregistration

Dutch manufacturers or authorised representatives of non-EU manufacturers established in the Netherlands are obliged to register (notify) certain risk classes of medical devices and …

Dutch MDR/IVDR implementation: Medical Devices Regulation …

https://mdlaw.eu/ivdr/dutch-mdr-ivdr-implementation-the-dutch-medical-devices-regulation-and-the-dutch-medical-devices-act/

Dutch MDR/IVDR implementation: Medical Devices Regulation and Medical Devices Act. on April 29, 2022. The Dutch Regulation of the Minister for Medical …

European regulations for medical devices and IVDs

https://english.igj.nl/medical-technology/new-european-regulations-mdr-and-ivdr

Regulations for medical devices. The European regulation for medical devices (Medical Device Regulation, MDR) became applicable on 26 May 2021. The MDR replaces the …

Notifications | Medical devices and in vitro diagnostic

https://english.farmatec.nl/medical-devices/notifications

Netherlands-based manufacturers or their authorised representatives are obliged to submit notifications when marketing medical devices or procedure packs that belong to one of …

Medical Device Registration and Approval in Netherlands

https://arazygroup.com/medical-device-registration-netherlands/

In the Netherlands, devices are regulated by the Ministry of Health, Welfare and Sport Agency, CIBG Farmatec. CLASSIFICATION SYSTEM: Medical devices are classified …

Medical Devices Regulatory Services - Freyr Solutions

https://medicaldevices.freyrsolutions.com/medical-devices-regulatory-services-netherlands

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 …

Netherlands medical devices compliance update

https://medicaldeviceslegal.com/2014/01/20/netherlands-compliance-update/

The Dutch have clearly decided that they are going to make a difference in the medical devices space, which I much applaud as there was certainly room for …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

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