Medical Products: Accreditation and Notification

As a nationally and internationally active body in the field of medical devices, we are subject to strict requirements regarding our organisation, competence, neutrality and independence. These requirements are defined by the respective bodies responsible (statutory provisions, international standards, regulations, rulings, recommendations) and regularly checked for compliance (audits). The defined requirements also have a direct influence e.g. on the agreements and contracts that we have concluded with you, on our work at your facilities and as regards our planning and assessments at the certification body. 

In the field of medical devices we are subject to the basic requirements, and in certain fields of work also the special requirements,

• of the “Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices” (ZLG), and the resolutions and recommendations of the “European Commission”, within the framework of our appointment as a notified body for medical devices (identification number 0044) according to (EU) 2017/745 Medical Devices Regulation (MDR) and under European Directives 93/42/EEC
• of the German accrediting body “Deutsche Akkreditierungsstelle” (DAkkS), within the framework of our accreditation as a certification body for quality management systems under the standard DIN EN ISO 13485.
• of the “Standards Council of Canada” (SCC), within the framework of the CMDCAS programme (“accepted registrar”).
• MDSAP (Medical Device Single Audit Program), the accreditation for which is held by TÜV USA.

These requirements are subject of continually changes e.g. changes in accreditation system, national/international standards (norms, guidelines) or relevant regulatory requirements (EC directives and regulations).