Netherlands Medical Device Regulations

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Rules for manufacturing and using medical devices

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

For Class I medical devices (non-sterile and/or non-measuring) you assess if the product complies with the Medical Devices Directive yourself. If this is the case, you may put the CE marking on the product. Medical devices Class IIa, IIb, and III must be inspected by an independent authority (Notified Body). If this … See more

Medical devices: MDR and IVDR in the Netherlands

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 …

Medical Device Regulation | Deloitte Nederland - Deloitte …

https://www2.deloitte.com/nl/nl/pages/life-sciences-en-gezondheidszorg/solutions/medical-device-regulation.html

The MDR replaces the present Medical Device Directive (hereinafter: “MDD”). As of 26 May 2021 the MDR actually applies, which means that manufacturers of medical devices …

Registration of a medical device or IVD | Medical …

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

Manufacturers may place a medical device or in vitro diagnostic device (IVD) in Europe only if it complies with the statutory requirements. The Health and Youth Care …

Medical Device Registration and Approval in Netherlands

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

Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the …

Netherlands Medical Device Registration, notification, …

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

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European Medical Device Regulation | Deloitte Netherlands

https://www2.deloitte.com/nl/nl/pages/risk/solutions/european-medical-device-regulation.html

We are specialised in Quality and Regulatory Compliance for Medical Devices in particular Regulation (EU) 2017/745 (EU-MDR). We assist manufacturers and other economic …

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/

The Dutch Regulation of the Minister for Medical Care(cited as the Dutch Medical Devices Regulation) of 23 April 2020 and the Law 400 from 24 October 2019 on …

List of Countries without Formal Regulatory Approval …

https://www.regdesk.co/countries-no-medical-device-regulations/

Aruba, British Virgin Islands, Cayman Islands, Netherlands Antilles and the Turks and Caicos have no formal medical device regulatory requirements. However, as Overseas Countries and Territories of the EU, …

Ministry of Health, Welfare and Sport | Government.nl

https://www.government.nl/ministries/ministry-of-health-welfare-and-sport

Everyone in the Netherlands has health insurance that covers a broad range of treatment and care. The ministry works with health insurers, providers and patient organisations to ensure sufficient facilities and …

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