- The new Medical Device Regulation (MDR) establishes the rules for the placing on the market and making available of Medical Devices and Accessories in the European Union market, thereby facilitating the free movement of products within EU countries.
- Ensuring a high level of safety and health for Medical Devices requires a thorough revision of the 93/42/EEC Medical Device Directive, to create a transparent, traceable, and sustainable regulatory framework.
- The oversight of Notified Bodies, conformity assessment procedures, Clinical Investigations and Clinical Evaluation, Vigilance and Market Surveillance, and Audits should be significantly strengthened as key elements.
- Before MDR, Implantable Active Medical Devices were regulated under the 90/385/EEC Directive, and Medical Devices were regulated under the 93/42/EEC Directive, with two separate legal documents. For simplification, a single legislative act should be applicable to all Medical Devices, except for In Vitro Diagnostic Devices (IVDs), replacing both of these frequently amended directives.
- The scope of this Regulation should be clearly distinguished from other EU harmonization legislation related to In Vitro Diagnostic Devices (IVDs), Medical Products, Cosmetics, and Food, and should be exclusively focused on Medical Devices.
MDR Requirementadmin2024-12-04T01:59:58+03:00