Dutch Medical Device Law

At Manningham Medical Centre, you can find all the data about Dutch Medical Device Law. We have collected data about general practitioners, medical and surgical specialists, dental, pharmacy and more. Please see the links below for the information you need.

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 - Government.nl

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

The revised regulation also poses demands on medical devices and in vitro diagnostics devices you yourself develop for use in your institution. Read more about the …

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 …

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 trial. For …

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 the …

CMS | Netherlands | Medical Devices and Diagnostics | Law

https://cms.law/en/nld/global-reach/europe/netherlands/expertise/life-sciences-healthcare/medical-devices-and-diagnostics

Medical devices and diagnostics are quickly evolving, integrating innovative tech solutions that use and generate increasing amounts of data. They …

Monitoring the quality and safety of medicines

https://www.government.nl/topics/medicines/monitoring-the-quality-and-safety-of-medicines

The Medicines Act (in Dutch) lays down rules so that medicines are used safely. For instance: doctors and pharmacists have to report serious side effects; doctors must …

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 …

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 …

Dutch medical devices law due in February 1995:

https://medtech.pharmaintelligence.informa.com/MT090338/Dutch-medical-devices-law-due-in-February-1995

The Health Ministry has confirmed that KEMA, based in Arnhem, has been designated a Notified Body for all conformity assessment procedures with regard to all …

Need more information about Dutch Medical Device Law?

At Manningham Medical Centre, we collected data on more than just Dutch Medical Device Law. There is a lot of other useful information. Visit the related pages or our most popular pages. Also check out our Doctors page.