[Focus Notified Bodies. New requirements for designation and monitoring].
For medical devices with a higher risk, Notified Bodies assess whether the manufacturers and their products fulfill the requirements laid down in the European directives on medical devices. Notified Bodies are designated through a designation procedure by the designating authority, in Germany by ZLG. The requirements for the designation arise from the respective annexes of the directives on medical devices. Since these are only minimal criteria, different documents have been compiled on a European and national level to concretize these minimal criteria regarding the organization, quality management system, resources, and certification procedure. The rules of the ZLG are thereby the essential documents for designation in Germany. Moreover, according to Implementing Regulation (EU) no. 912/2013, the European commission and the other European designating authorities also have to be involved in the designation process. The aim of continuous monitoring of the Notified Bodies with assessments on the bodies' premises as well as with observed audits is to ensure the permanent fulfillment of the requirements. If nonconformities are found in a body's quality management system or in its implementation of the conformity assessment procedures, the body is obliged to provide ZLG with a corrective actions plan. In the case that the nonconformities are not resolved in time or critical nonconformities are found, ZLG may take actions, e.g., restrict the scope of designation, suspend, or - as last resort - withdraw the designation.
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, Heinrich-Böll-Ring 10, 53119, Bonn, Deutschland, ulrich.poos@zlg.nrw.de.
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D004282:Documentation / Q000592:standards*; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D005858:Germany; D033161:Government Regulation; D019221:Mandatory Reporting; D019300:Medical Errors / Q000331:legislation & jurisprudence / Q000517:prevention & control; D061214:Patient Safety / Q000331:legislation & jurisprudence / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D017751:Safety Management / Q000331:legislation & jurisprudence* / Q000592:standards