The new 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 new 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 new EU MDR requirements with the following services:

 

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

  • 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 in to higher risk classes of devices;
  • Reconfirm 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). Confirm the status of Certificate expiry dates and prepare an EU Compliance Strategy for each device.

2. Gap Assessment

  • Quality Management System (QMS) requirements including all current policies, processes, and procedures against MDR requirements
  • Technical Documentation requirements (Technical Files and/or Design Dossiers) against MDR requirements
  • Labeling requirements (including required languages in each Member States) against MDR requirements
  • Unique Device Identification (UDI) System against MDR requirements
  • Requirements for EUDAMED Database
  • Risk Management System (RMS) against MDR requirements
  • Clinical Data Requirements against MDR requirements
  • Safety and Performance Requirements against MDR requirements
  • Post-Market Surveillance System (PMS) against MDR requirements
  • Vigilance Activities against MDR requirements
  • Market Surveillance Activities against MDR requirements
  • Requirements regarding Design and Manufacture of Devices per MDR requirements
  • Supply Chain Requirements against MDR requirements

3. Remediation and Implementation of EU MDR Compliance Plan

  • Remediation of EU MDR Compliance Gaps noted during Assessment
  • Development of an EU MDR Compliance Plan for systems and devices
  • Implementation of EU MDR Compliance Plan for systems and devices
  • Staff Augmentation and Support
  • Readiness Audits / Pre-Certification Audits and/or Assessments

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