In Vitro Diagnostics Regulation (EU IVDR) Training

ANSWERED ON THIS PAGE:

  • What can our employees learn that will help them with IVDR compliance?
  • What does our company need to do for IVDR recertification?
  • Can we train our team on IVDR implementation for a reasonable price?

The European Union issued both the Medical Devices Regulation (MDR 2017/745/EU) and the In Vitro Diagnostics Regulation (IVDR 2017/746/EU) in May 2017 to supersede the regulatory schemes currently in place. While the MDR takes effect in May 2021, IVDR implementation does not occur until May 2022. Despite this seemingly distant deadline, it is recommended that IVD manufacturers start now learning about the new system and its more stringent requirements in certain areas. This new focus will lead to more complicated procedures for conformity assessment, stricter standards for determining equivalence, and much greater importance of clinical evidence.

IVDR compliance will lead to numerous challenges for manufacturers, including in many cases their first interactions with Notified Bodies during the conformity assessment process. A shared understanding of the new system will be critical for team efforts going forward. The detailed IVDR training that Emergo by UL offers is crafted to prepare your company for the challenges posed by IVDR implementation, and enable a stable and predictable transition.

What your team learns in a training session on the European IVDR (2017/746/EU)

Over two days of training, your company’s employees will develop a comprehensive understanding of the IVDR. Your team will conduct workshops with fictional IVDs or sample(s) of your company’s actual products. You will learn the following and more:

  • Scope of the IVDR and products that fall within the definition of an in vitro diagnostic device
  • Economic Operators – their roles and responsibilities
  • UDI requirements in Europe
  • Classifying IVDs under the European IVDR
  • Conformity assessment procedures and the role of Notified Bodies
  • Changes under the General Safety and Performance Requirements (GSPR) compared to the Essential Requirements
  • Technical Documentation under the IVDR and areas of focus during Notified Body assessments
  • Performance evaluations (Scientific Validity, Analytical Performance and Clinical Performance)
  • Performance studies and EU Reference Laboratories
  • Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
  • Vigilance requirements for Europe
  • The role of the Personal Responsible for Regulatory Compliance (PRRC)
  • Planning your transition to the IVDR

The training schedule provides time for discussion among the team after each module. By the time the training is complete, your team members should feel empowered to provide answers to most IVDR questions that arise in the course of their daily routines.

On-site or remote EU IVDR training with experienced regulatory consultants

Our IVDR training sessions provide excellent return on investment for companies training three or more employees at once. The training can take place at your facility (with remote training options also available) and is led by senior regulatory consultants with extensive real-world experience addressing IVDR compliance, not just teaching about it. They are in touch with industry needs, and advocate a practical approach to the Regulations. A private venue gives your employees the freedom to ask questions specific to their individual job functions, which they may not be able to do in local hotel-based group classes with competitors in the same room. On-site or remote training also guarantees that every employee receives consistent information for a fixed price, no matter how many employees attend.

IVDR implementation may seem far away, but smart companies will begin preparing for it now. Contact us to receive more information or a proposal for intensive EU IVDR training conducted at your own facility.

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