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The New Medical Device Regulation (MDR), which is replaced by European MD Directive 93/42/EEC (EU MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMD) had a timeline of May 2020. The timelines have been extended to May 2021, due to the COVID-19 pandemic. These extended timelines have given an opportunity for the manufacturers with the devices already being marketed, as well as those planning to introduce in coming years to comply with EU MDR regulations and obtain CE marking.

The MDR - Transition Timeline and New Device Classifications

The European Medical Device Regulation (MDR) will be fully effective in all the EU member states and the European Free Trade Association (EFTA) States from May 2021 and provides manufacturers a transition period of 4 years for complete EU MDR Certification.

The new European Medical Device Regulation (MDR), as observed, have also brought changes to existing device classification system such as:

From identifying exact changes to be made to implementing them in real-time, manufacturers may have to navigate through array of challenges to comply with EU MDR requirements. Right from decoding the new structure, classifying a device accurately, to collate and submit all the data, a more detailed and cross-functional Regulatory approach will be required for manufacturers, to cope with the new European Medical Device Regulations. With a stringent gap analysis, Freyr assists clients with the status-quo and there by provides necessary Regulatory action needed for the transition and EU MDR Compliance.

Freyr Expertise and Advantages

Freyr Expertise

  • Developing a clear Medical Device Regulation (MDR) implementation strategy
    • Understanding the new legislation, conducting Gap Analysis to current Quality Management Systems (QMS) and processes in place
    • Developing a detailed plan with a cross-functional approach to determine aspects of quality system that will need modification in purview with the new EU Medical Device Regulation
    • Forming multiple teams for analyzing product scope, classification, handling QMS etc., within organization, with a single point of contact in each team
    • Allocation and planning of resources
    • Considering your QMS interaction with other regulations and utilizing this opportunity to streamline processes, while allowing flexibility to incorporate future changes
    • Analyzing the test data in place and check for any additional requirements that MDR puts in place
    • Coordinating expectations and transition plan with your EU Notified Bodies
  • Gap Analysis for existing Medical Devices from the EU MDD to the EU MDR Regulations
  • End-to-end support to develop Clinical Evaluation Report (CER), including, literature search as per European Medical Device Regulation (EU MDR) guidelines
  • End-to-end services for Post-market Surveillance Reports (PMSR), Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP)
  • Regulatory Resource Augmentation with both onshore and offshore deployment options
  • European Authorized Representative (EAR) Services
  • MDR Compliance and submission assistance to Notified Bodies
  • Regulatory Intelligence covering importation process of different regulated markets
  • QMS Compliance and mock audits
  • Document Management System and tool for MDR companies
  • Classification and reclassification of devices according to risk
  • UDI implementation and consulting
  • EU Medical Device Regulation Compliant Post-market Surveillance services
  • Risk Management ISO 14971 consulting
  • In-house and online training
  • Person responsible for Regulatory compliance services and assistance
  • Identification of MDR Notified Bodies