The Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd or IGJ) is the Dutch government agency within the Ministry of Health, Welfare and Sport responsible for public health policies. The IGJ was formed in 2017 with the merger of two institutions: the Dutch Healthcare Inspectorate and the Dutch Inspectorate for Youth Care.
The IGJ supervises almost all aspects of Dutch healthcare (e.g., physiotherapists, dentists, hospitals, long-stay care units, IVD laboratories, psychiatrists, etc.). Together with medicinal products, the section for Medical Technology oversees medical products as part of the work of the IGJ. The supervision is based on European legislation supported by specific Dutch legislation. Part of this task is to oversee investigations of incidents by providers of care and/or medical products or to perform independent investigations. For medical devices, the IGJ also oversees the activities of Dutch Notified Bodies (DEKRA, BSI, and LRQA).
A list of EU regulations can be found here on our website.
Contact details:
在欧盟销售的医疗器械需要拥有一个证明其符合欧盟医疗器械法规的CE认证标志。CE标志表明法定制造商已评估器械,并且符合MDR 2017/745下的一般安全和性能要求(GSPR)。法定制造商将验证是否符合所有相关的欧盟要求,并必须在其欧盟符合性声明(DoC)中声明这一点。此外,高风险器械(MDR下
阅读更多