The "Preparing for the New EU Medical Device Regulations (MDR)" conference has been added to Research and Markets' offering.

The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2017. From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years to comply with the new set of rules.

Given the large scale of changes, there is great pressure on all actors to analyze the MDR, conduct impact assessments, and implement compliant processes. After May 2020, non-compliance threatens CE-mark certification, access to the European market, or, in the case of Notified Bodies, re-designation.

The European Union released the Medical Devices Regulation (MDR 2017/745/EU) to eventually replace the Medical Devices Directive and Active Implantable Medical Devices Directive. The MDR introduces numerous changes, including a shift from the pre-approval stage to more of a life-cycle approach.

It also incorporates a variety of European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluations, and Post-Market Clinical Follow-up (PMCF). MDR compliance presents many new challenges to medical device manufacturers. Our in-depth MDR training is designed to help you and your team prepare for these challenges and transition smoothly to the MDR.

This seminar provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the product lifecycle. You will gain a strong foundation of the key elements of the EU directives governing medical devices.

These include: Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC, Medical Devices Directive (MDD) 93/42/EEC and In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC in their latest revision, including the 2007/47/EC amendments to AIMDD and MDD.

This course examines how devices are classified, and the effect classification has on labeling, registration, marketing and postmarketing requirements. Learn about the new requirements in the Medical Device Regulation (MDR), including those related to quality systems, product classification rules, technical documentation, clinical evaluations, Unique Device Identification (UDI), and postmarket surveillance; and more importantly learn how to plan an efficient transition.

Learning Objectives:

  • Class I, II and III/In Vitro Diagnostic medical device manufacturers
  • Contract medical device manufacturers
  • Contract sterilizers
  • Repackagers, relabelers, specification developers, reprocessors of single-use devices
  • Manufacturers of accessories and components sold directly to the end user
  • U.S. manufacturers of "export only" devices
  • Distributors
  • Importers
  • User Facilities (e.g., hospitals, nursing homes)

For more information about this conference visit https://www.researchandmarkets.com/research/n43pb4/two_day_seminar?w=4