ABSTRACT
Medical Devices bearing a marking indicating the European Conformity Assessment to regulations the—CE mark—are considered to be cleared in the European Union market. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements hence to be in compliance with the EU conformity assessment regulations. CE marking is also in place in Turkey, following the Ankara Agreement between EU and Turkey. Harmonized standards are European standards prepared in accordance with the General Guidelines agreed between the Commission and the European standards harmonization, and follow a mandate issued by the Commission after consultation with the Member States. The European Commission helps to shape the EU’s overall strategy, proposes new EU laws and policies such as the MDR and IVDR regulations, monitors their implementation and manages the EU budget.
