Dutch Medical Devices Act

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Rules for manufacturing and using medical devices

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

Medical devicesare products used for diagnoses and treatments in the healthcare sector or products that can help prevent or predict diseases or disorders. For instance: 1. wheelchairs 2. breast implants 3. surgical instruments 4. pacemakers 5. software If you are not sure if your product is a medical device, the Euro… 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/

In all EU-countries, so-called Notified Bodies assess medical devices and their compliance with regulations. Medical devices that meet the legal standards are given a CE …

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 …

Medical devices | RIVM

https://www.rivm.nl/en/medical-devices

Medical devices are products which are covered by the Medical Devices Act. In practice, this comes down to all the equipment, software and consumables which …

Medical Device Registration and Approval in Netherlands

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

In the Netherlands, you are legally obliged to register medical devices or IVD’s if you are: a manufacturer or a European authorized representative established within the Netherlands …

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 …

Rules for clinical trials - Health and Youth Care Inspectorate

https://english.igj.nl/medicines/clinical-trials-gcp/rules-for-clinical-trials

Individual healthcare professions act (BIG Act) (in Dutch) Healthcare quality, complaints and disputes act (Wkkgz) (in Dutch) Additional legislation may also apply to a clinical …

Pharmaceutical & medical device advertising regulation …

https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/netherlands

The Medical Devices Act is the primary law on medical devices, but the law does not have a specific section on advertisement. Advertising is regulated in some …

The Dutch Medical Devices Act: Problems with …

https://www.jstor.org/stable/26658646

1988 DUTCH DEVICE ACT 409 Amendments, the Dutch Act does not provide that medical devices be tested for effectiveness." Only three decrees concerning quality have come …

PC100 Thrombocyte / platelet counter - Dutch Medical Devices

https://www.dutchmedicaldevices.com/

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