The EU Medical Device Regulation (MDR) was published in the Official Journal of the European Union on May 5, 2017. The Regulation entered into force on May 25, 2017. The EU MDR replaces the Medical Device Directive (MDD) [93/42/EEC] and the Active Implant Medical Devices Directive (AIMD) [90/385/EEC].

 

Transition Period for EU MDR Compliance

The Transition Period began on May 27, 2017, for medical device manufacturers selling medical devices into Europe. Regulatory Compliance Associates® Inc. can assist clients that need to comply with the EU MDR requirements with the following services:

 

1. Preform a Comprehensive Review of Entire Product Portfolio and Current Certificate Expiry Dates

  • Review and Assess the Client’s entire Product Portfolio including its:
    • Legacy Products [CE marked devices under the Medical Device Directives (MDD) 93/42/EEC or the Active Implantable Medical Device Directive (AIMD) 90/385/EEC];
    • Modified Legacy Products; and/or
    • New Products currently in the Design/Development Phase.
  • Confirm whether any Legacy Products and/or Modified Legacy Products have been affected by the new MDR Definitions and/or Reclassification of certain types of products into higher risk classes of devices;
  • Reassess current classification of devices based on MDR Classification Rules;
  • Prepare Product Rationalization Strategy Reports for Legacy Products, Modified Legacy Products, and New Products (as appropriate and applicable). which may assist the Client in making internal decisions about whether to maintain and/or bring such products in compliance with the MDR;

2. Staff Augmentation and Support

  • Readiness Audits / Pre-Certification Audits and/or Assessments

3. Perform a Gap Assessment of the current Quality Management System (QMS) and its Current Processes and Procedures for MDR Compliance.

  • Review and Assess the Quality Management System (QMS) requirements including all current policies, processes, and procedures against ISO 13485:2016 requirements
  • Technical Documentation requirements
    • Labeling requirements (including required languages in each Member States)
    • FDA Unique Device Identification (UDI) System
    • Data entered into the EU MDR EUDAMED Database per Article 33
    • Risk Management System (RMS) 
    • Risk Management Plan and Report dor each device
    • Clinical Data Requirements
    • Safety and Performance Requirements
    • Post-Market Surveillance System (PMS)
    • Vigilance Activities
    • Market Surveillance Activities
    • Requirements regarding Design and Manufacture of Devices per MDR requirements

4. Remediation and Implementation of EU MDR Compliance Plan

  • Supply Chain Requirements
  • Development and Implementation of EU MDR Compliance Plan for systems and devices
  • Remediation of EU MDR Compliance Gaps noted during Assessment
  • Development and Implementation of EUDAMED Database compliance plan for all of the following six pillars of the EUDAMED
    • Actor Registration
    • Unique Device Identification
    • Certificate
    • Clinical Investigation
    • Vigilance

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