EU Medical Device Regulation (MDR) 2017/745

Course Description

This two-day training on the Medical Device Regulation (MDR) 2017/745 is to provide Medical Device Manufacturers an overview of the MDR.

Who Should Attend

Quality and Regulatory professionals including individuals in the Medical Device Industry who need to understand the MDR and know what to do to comply with it today and tomorrow. A good understanding of the MDD would be beneficial.

Topics Include

  • Background on CE-Marking

  • Intent of the change from MDD to MDR

  • Similarities between the MDD and MDR “process”

  • Format of the MDR to understand the Chapter, Article and Annexes

  • New Responsibilities and authorities of all parties involved, including: Notified Bodies, Competent Authorities, Authorized Representatives, Expert Panels, Economic Operators, Importers, Distributors, Manufacturers and the Person Responsible for Regulatory Compliance

  • Device Classifications including:

    • Single Use Device & Reprocessing

    • System & Procedure Pack

  • Technical Documentation (replacing Technical File/Design Dossier)

  • General Safety and Performance Requirements (GSPR) (replacing Essential Requirements)

  • Harmonized Standards, Common Specifications and Guidance documents

  • Initial Assessments, Technical Documentation review, Continuous Assessments

  • Routine Product Testing at the Manufacturer, Supplier and on the Market

  • Clinical Evaluation

    • Clinical Evaluation Plan (CEP)

    • Clinical Development Plan

    • Clinical Investigation Plan/Report

    • Summary of Safety and Clinical Performance (SSCP)

    • Clinical Evaluation Report (CER)

  • Post Market Surveillance (PMS)

    • Post Market Surveillance (PMS) Plan

    • Post Market Clinical Follow-Up (PMCF) Plan/Report

    • Periodic Safety Update Report (PSUR)

    • Post Market Surveillance (PMS) Report

  • Vigilance including Trend Reporting

  • European Database on Medical Devices (Eudamed)

  • Unique Device Identification (UDI)

  • MDD to MDR Transition timing and requirements

  • Official changes to the MDR (corrigendum)

  • What to do today and what to expect tomorrow

  • Where to go for guidance

 

16 Hours


Contact Information

Email
paulette@pyyoungassociates.com

Phone
1 (650) 967-2700

Address
P.O. Box 2103
Sunnyvale, CA 94087-0103