EU Medical Device Regulation (EU MDR)

The EU Medical Device Regulation (EU MDR), officially known as EU Regulation 2017/745, is the primary regulatory framework governing the safety, performance, and market approval of medical devices within the European Union (EU) and the European Economic Area (EEA).

Here is a comprehensive overview of the EU MDR, its requirements, and its context within the medical device industry:

1. Regulatory Context and Scope

• Replacement of MDD: The EU MDR (EU Regulation 2017/745) replaced the former Medical Device Directive (MDD), imposing stricter requirements on manufacturers, suppliers, and distributors of medical devices.
• Compliance Mandate: Due to the introduction of the MDR, manufacturers who held a CE mark under the MDD must undergo the transition process to continue selling their products on the EU market.
• MDD-to-MDR
• Compliance Timeline (Transition Periods): While the MDR became fully applicable in May 2021, and the application deadline for transitional devices passed in May 2024, extended transition periods are available for eligible devices, provided the manufacturer submitted an MDR application on time and implemented a compliant Quality Management System (QMS).
  • Class III and Class IIb implantable devices have an extended deadline until December 31, 2027.
  • Other eligible devices (Class IIb, Class IIa, and eligible Class I) have an extended deadline until December 31, 2028.
• Stricter Focus: The MDR places greater emphasis on clinical evaluation, Post-Market Surveillance (PMS), traceability, and detailed technical documentation compared to the MDD.

2. Mandatory Manufacturer Obligations and QMS

The MDR mandates comprehensive obligations for manufacturers, which are primarily detailed in Article 10 (General obligations of manufacturers) and must be integrated into the QMS.

• QMS Requirement: Manufacturers must establish a robust Quality Management System (QMS) that ensures devices in production remain in conformity.
  • The QMS requirements in the MDR largely correspond to the sections of the QMS standard EN ISO 13485:2016.
  • The QMS must specifically address requirements related to: risk management (Annex I, Section 3), clinical evaluation (Article 61 and Annex XIV), and verification of Unique Device Identification (UDI) assignments (Article 27(3) and Article 29).
• Change Management: The QMS must include specific procedures for change management to address changes to the design or harmonized standards in a timely manner.
• Risk Classification: The MDR introduced new, more rigid classification rules, meaning many devices previously classified as low-risk (Class I under MDD) now fall under higher classes (Class IIa or higher).
  • Classification is risk-based: Class III devices (e.g., pacemakers) are high-risk, while Class IIb devices (e.g., ventilators) are medium- to high-risk.
• Person Responsible for Regulatory Compliance (PRRC): Manufacturers must assign a PRRC.
• Registration: Manufacturers must register their organization in EUDAMED (the European database for medical devices).
• General Safety and Performance Requirements (GSPRs): The MDR requires manufacturers to ensure that products integrate the requirements described in Article 10.4 of the MDR (Annex I, General Safety and Performance Requirements).

3. Traceability and Unique Device Identification (UDI)

The MDR imposes comprehensive requirements for device identification and traceability:

• UDI Requirements: Devices must adhere to Unique Device Identification (UDI) requirements and revise labeling accordingly.
• UDI Components: A device must be assigned three UDI identifiers:
  • Basic UDI-DI: Used in EUDAMED, on the Declaration of Conformity, and in documentation describing the category of products.
  • UDI-DI and UDI-PI: Used to differentiate model variants, production batches, dates, software versions, etc..
• Traceability Purpose: UDI traceability is essential in case of adverse events, field safety corrective actions, or product withdrawals.

4. Post-Market Requirements (PMS and CAPA)

The MDR demands enhanced post-market activities, which rely heavily on the QMS and CAPA (Corrective and Preventive Action) systems:

• PMS Implementation: Manufacturers must fully implement the updated Post-Market Surveillance (PMS) requirements, even if their existing certification is still under the MDD.
  • Annex IX (Conformity Assessment Based on a QMS and PMS) requires manufacturers to systematically monitor product performance, analyze post-market data, identify trends, investigate nonconformities, and implement corrective actions, verifying their effectiveness.
• CAPA System: The MDR requires manufacturers to establish a robust CAPA system to address product issues and ensure ongoing compliance. Manufacturers must document corrective and preventive actions, assess their effectiveness, and integrate them into their overall QMS.
• Vigilance Reporting: Serious incidents and Field Safety Corrective Actions (FSCAs) identified through PMS must be systematically investigated and resolved. The MDR mandates timely reporting of device-related risks, reinforcing regulatory adherence. Article 10, 13 specifies requirements for reporting serious incidents and FSCAs.

5. Conformity Assessment and Certification

• Notified Bodies: For all devices classified as Class IIa, IIb, III, and certain Class I devices, Notified Body involvement is required to conduct the conformity assessment. Notified Bodies are EU-authorized organizations that assess whether a device meets MDR standards and issue CE certificates.
• MDR Certification Audits: The Notified Body will conduct readiness and full MDR compliance audits, treating certification as a new market entry.
• Declaration of Conformity: After passing the audits, the manufacturer signs the Declaration of Conformity, confirming the device meets MDR requirements.

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