Medical image management systems are subject to the requirements of the Medical Products Act (MPG) in Germany. This includes systems for the primary diagnosis of X-rays.

The MPG derives from legal prescriptions for the use of medical technology that have been in force all over Europe for some years. It does not only address the product, but also the manufacturer.

Manufacturers are subjected to continual quality management monitoring to ISO standards in all relevant sectors - involving aspects like development, risk management and support. The image management system itself is classified and certified in its area of operation by a notified body, i.e. a state accredited controlling organisation. This is repeated at regular intervals to ensure consistent quality.

The resulting certification of a business or product is confirmed by a certificate. Various implementation rules and DIN specifications control the details of a system, for instance the requirements for image reproduction equipment.

	Medical Products Act (MPG) The MPG classifies medical products by intended use, regulating distribution and determines the rights and duties of the sellers and users of medical products.
	ISO Certification
	For ISO certification, a state accredited, independent third party confirms that a product, process, service or an entire organisation meets certain specified requirements (e.g. a quality management system). If so, a certificate is awarded.
	DIN 6868
	DIN 6868 Part 57 describes how to test the image quality provided by image generating equipment (monitors) for the diagnosis and examination of medical image data in conjunction with a PACS image information system.
	X-ray Act (RöV)
	The X-ray Act (RöV) §28 regulates the manner of recording and the duration of storing data and images in X-ray diagnostics.
	Quality Assurance guidelines (QA guidelines)
	The QA guidelines are there to ensure uniform and consistent acceptance and consistency tests on X-ray equipment and image reproduction equipment (monitors) used in human medicine, for both X-ray diagnosis and radiotherapy.
	Guidelines for Technical Expert Inspection (SV guidelines)
	The Guidelines for Technical Expert Inspection ensure the uniform and consistent technical inspection of X-ray equipment and certifiable radiation sources by authorised experts in accordance with article 5 section 1 of the X-Ray Act of 8 January 1987 (Federal Code 1, page 114) as amended on 30 April 2003 (Federal Code 1, page 604).

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