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What is the difference between MDR and MDD for medical devices?

The Medical Device Regulation (MDR) and the Medical Device Directive (MDD) are two regulatory frameworks governing the safety and performance of medical devices in the European Union. The MDR replaced the MDD, introducing more stringent requirements. Here are the key differences:

Scope and Coverage

  1. MDD (Medical Device Directive):
    • Applied to a broad range of medical devices, but had some limitations in scope.
    • Primarily focused on ensuring safety and performance through conformity assessment procedures.
  2. MDR (Medical Device Regulation):
    • Expands the scope to include a wider range of products, such as devices without a medical purpose (e.g., cosmetic implants and contact lenses).
    • Includes software as a medical device and accessories.

Regulatory Framework

  1. MDD:
    • Was a directive, meaning each EU member state transposed it into national law, leading to variations in implementation.
    • Less prescriptive and more open to interpretation.
  2. MDR:
    • Is a regulation, which means it is directly applicable in all EU member states without the need for national transposition.
    • Provides a more harmonized and detailed regulatory framework.

Classification and Conformity Assessment

  1. MDD:
    • Used a risk-based classification system (Class I, IIa, IIb, III).
    • Conformity assessment procedures varied by class, with many Class I devices self-certified by manufacturers.
  2. MDR:
    • Retains the risk-based classification but introduces more stringent criteria.
    • Requires greater involvement of Notified Bodies, especially for higher-risk devices and some Class I devices that previously were self-certified.

Clinical Evaluation and Post-Market Surveillance

  1. MDD:
    • Required clinical evaluation but was less stringent about the extent and depth of clinical data needed.
    • Post-market surveillance requirements were less comprehensive.
  2. MDR:
    • Requires more rigorous clinical evaluations, with increased emphasis on clinical evidence and post-market clinical follow-up.
    • Strengthens post-market surveillance requirements, including mandatory reporting of serious incidents and periodic safety updates.

Documentation and Traceability

  1. MDD:
    • Required technical documentation but allowed for variations in the depth and detail provided.
    • Traceability requirements were less developed.
  2. MDR:
    • Introduces the Unique Device Identification (UDI) system for better traceability of devices.
    • Requires more comprehensive technical documentation and a Summary of Safety and Clinical Performance (SSCP) for higher-risk devices.

Transparency and Vigilance

  1. MDD:
    • Had less emphasis on transparency and public access to information.
    • Vigilance reporting systems varied by country.
  2. MDR:
    • Enhances transparency with the European Database on Medical Devices (EUDAMED), providing access to information about devices, manufacturers, and conformity assessments.
    • Standardizes vigilance and reporting requirements across the EU, with stricter timelines for reporting adverse events.

Economic Operators

  1. MDD:
    • Defined roles for manufacturers, authorized representatives, and importers but with less clarity.
  2. MDR:
    • Clearly defines and delineates responsibilities for manufacturers, authorized representatives, importers, and distributors.
    • Imposes more stringent requirements on these economic operators to ensure compliance.

Overall, the MDR aims to enhance patient safety, increase transparency, and ensure a more robust regulatory framework for medical devices in the EU, addressing some of the weaknesses and inconsistencies of the MDD.

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