The In Vitro Diagnostic Devices Regulation (IVDR 2017/746) is the legislation detailing the requirements which manufacturers have to meet to place in vitro diagnostic devices on the market in the European Union.

The Regulation contains detailed requirements that need to be implemented, and will affect all IVD manufacturers, importers, distributors and EU Representatives.

The IVDR focusses on devices to be safe and effective, emphasizing pre-market requirements, conformity assessment, post-market-surveillance (PMS), and traceability.

This course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business.

Course Aim

To help implement the requirements of the European In Vitro Diagnostic Device Regulation (IVDR 2017/746) to obtain and maintain the CE mark for your product. Gain confidence with the IVD classification rules and the conformity assessment routes. Learn the importance of the General Safety and Performance Requirements in product development, and of scientifically robust performance evaluation and clinical evidence. Explore the role of risk management during product development and in post market follow up. Develop an understanding of the interface and interaction with Notified Bodies, economic operators (importers, distributors, EU Representatives) and subcontractors/suppliers, according to their obligations under the IVDR.

How will I benefit?

This course will help you:

• Take the necessary steps for your organization to meet the IVDR requirement
• Implement the requirements of the European In Vitro Diagnostics Devices Regulation
• Execute robust and compliant performance evaluation and post market follow up studies
• Guide and support other people and partner organisations affected by IVDR

What will I learn?

By the end of the course delegates will be able to:

• Develop a strategy for regulatory compliance as stipulated by IVDR
• Recognise the roles and responsibilities of Economic Operators (legal manufacturer, Authorised representative, Importer and Distributor) and other Key Players (Notified Body, Competent Authority, significant subcontractors) under the IVDR
• Explore the role of the Notified Body
• Implement requirements concerning the following steps for Placing on the Market:
  • Scope and applicability of IVDR
  • EU risk classification criteria for IVDs to determine “Risk Class”
  • General Safety and Performance Requirements as the basis for CE Marking, including the use of standards and Common Specifications
  • Risk Management and related planning
  • Technical documentation
  • Labelling and UDI
  • Conformity assessment routes and their application based on risk-class
  • Self-certification, CE-certification by Notified bodies
  • Other key Regulations and Directives
  • EUDAMED and registration
• Plan post-market activities required by IVDR with respect to:
  • Post-Market Surveillance and post-market Follow-Up
  • Periodic reports, Vigilance, ad-hoc Reporting
  • Risk management throughout the product lifecycle
  • Involvement of authorities, scrutiny
  • Notification of significant changes
• Impart knowledge concerning IVDR requirements into your organization, e.g. in projects for CE-marking

Who should attend?

The course is especially suitable for:

• RA, QM, and QA professionals who will be implementing the IVDR within their organisations
• Personnel concerned with certification or active in projects for CE-marking, including R&D scientists, production personnel, project management.
• Staff in contact with IVD Device manufacturers at companies which are partners to manufacturer, e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee.

Duration

3 days

How will I learn?

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

Participants must have an understanding of the requirements in the IVDR, for example conveyed through our IVDD to IVDR transition course, or the 1 day Requirements of the IVDR training course.

Participants would benefit from an understanding of European In Vitro Diagnostic Device legislation, or some experience in pre-or post-market activities within the EU.

Further information

This course will focus on the overall implementation of the IVDR, and not on specific devices.

Detailed course notes are provided.

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.

Related training

Requirements of the IVDR

IVD Directive to IVD Regulation Transition

Technical files and design dossiers for In Vitro Diagnostics (IVDs)

Performance evaluation and clinical evidence for In Vitro Diagnostics (IVDs)

Risk Management for medical devices

Process validation

MDR courses