EU IVDR Compliance Training for In Vitro Diagnostic Manufacturers

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 importance of IVDR requirements

The IVDR introduces multiple changes to the way IVD manufacturers shall achieve and maintain compliance over the devices’ entire life cycle. In addition to the introduction of a rules-based classification system and significantly increased Notified Body involvement, a stronger emphasis is being placed on clinical data, as well as Performance Evaluation Plans/Reports, and the involvement of the manufacturer throughout the full life cycle of an IVD device. For a successful IVDR transition, it is therefore critical that all involved employees are aware of the IVDR and its impact on the organization.

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.

European IVDR training: Learning objectives

Emergo will provide a remote or on-site training covering the IVDR's regulatory requirements. Emergo offers different IVDR training options, each covering the same main IVDR topics but differing in the level of detail. 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 IVDR training

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 means that every employee receives consistent information for a fixed price, no matter how many employees attend.

Contact us to receive more information or a proposal for intensive EU IVDR training conducted at your own facility.