Medizinprodukteverordnung

Medizinprodukteverordnung is the term used in German-language contexts for the regulatory framework that governs medical devices placed on the market in the European Union. It generally refers to the rules derived from the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) and the EU In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746). The provisions apply to devices intended for medical purposes, including software used for diagnosis or treatment, accessories, and in vitro diagnostic devices, when marketed or operated in the EU.

Key elements of the regulation include a risk-based device classification, conformity assessment procedures, and the affixing of the CE mark to demonstrate conformity. Manufacturers must prepare technical documentation, perform clinical evaluation where required, and implement post-market surveillance. Higher-risk devices face more stringent requirements, including post-market surveillance plans and post-market clinical follow-up. The framework establishes vigilance and incident-reporting duties, updates on safety, and traceability measures such as a unique device identification system and access to information in the Eudamed database.

Economic operators, including manufacturers, authorized representatives, importers, and distributors, have defined responsibilities to ensure compliance. Notified bodies assess conformity for devices according to applicable classes, and national competent authorities oversee enforcement and market surveillance within member states.

In Germany, the medical devices framework is implemented through national legislation such as the Medizinproduktegesetz (MPG) and the Medizinprodukte-Durchführungsverordnung (MPDV), which transpose and supplement the EU MDR and IVDR. The MDR became applicable in 2021, with the IVDR following in 2022, subject to transitional arrangements.