Regulation (EU) 2017/745 (MDR) is the legal framework that governs all medical devices placed on the European market today. Fully applicable since 26 May 2021, it replaced Directive 93/42/EEC (MDD), introducing significantly more stringent requirements in terms of safety, performance, quality and transparency.
The MDR’s objective is as straightforward as it is ambitious: to ensure that only devices that are safe, traceable and supported by appropriate clinical evidence reach patients.
1. What has changed compared to the past?
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1. Cosa cambia rispetto al passato?
The MDR represents a deep and structural reform. Key changes include:
✔️ Stricter requirements for technical documentation
Technical documentation must clearly demonstrate the device’s safety, performance and effectiveness, supported by robust scientific and clinical data.
✔️Greater involvement of Notified Bodies
Many devices previously considered “low risk” must now undergo notified body assessment in order to obtain CE marking.
✔️ ✅ Strengthened post-market surveillance (PMS)
Manufacturers must actively monitor the device throughout its life cycle through PMS, PMCF and periodic assessments (PSUR).
✔️ Enhanced traceability (UDI)
Each device must have a Unique Device Identifier (UDI) to ensure traceability across the entire supply chain
✔️ Introduction of the PRRC
Each manufacturer, authorised representative or importer must have a Person Responsible for Regulatory Compliance (PRRC)—a mandatory role with demonstrated, appropriate competence.
[…]
Many devices previously considered “low risk” must now undergo notified body assessment in order to obtain CE marking.
✔️ ✅ Strengthened post-market surveillance (PMS)
Manufacturers must actively monitor the device throughout its life cycle through PMS, PMCF and periodic assessments (PSUR).
✔️ Enhanced traceability (UDI)
Each device must have a Unique Device Identifier (UDI) to ensure traceability across the entire supply chain
✔️ Introduction of the PRRC
Each manufacturer, authorised representative or importer must have a Person Responsible for Regulatory Compliance (PRRC)—a mandatory role with demonstrated, appropriate competence.
[…]
Each device must have a Unique Device Identifier (UDI) to ensure traceability across the entire supply chain