IVDR Fundamentals Training – Comprehensive Course to understand IVDR Requirements

This training is intended for the following target group:

• Employees in the IVD industry without previous knowledge
• IVD experienced staff with regulatory background
• Regulatory Affairs Officers
• Managers
• Authorized representatives, importers, distributors

• IVD-Regulation – Introduction
• Requirements to economic operators
• Classification – classification rules
• Conformity assessment procedures
• Technical documentation
• Requirements regarding performance evaluation
• Requirements regarding traceability (UDI / EUDAMED)
• Post-Market Surveillance (PMS), vigilance and market surveillance
• Summary

This course will provide a detailed overview of the new European Regulation 2017/746 related to In-Vitro Diagnostic Devices and is relevant to all parties and stakeholders involved in this specific field of the medical industry.

Course provides a detailed overview of the European Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices (IVDs) and points out the current developments.

Duration: 2 Days
Learning Mode: Online, Instructor-Led in a virtual classroom
Group Exercises: Yes
Exam: Yes
Certificate: Yes

Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.

The training program culminates in an online proctored exam in which you will need your webcam on.

The course content and structure are designed by the domain experts from TÜV SÜD. With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.

Participants will receive a certificate of Attendance by TUV SUD Academy. And upon successfully passing the respective exam: participants will earn a certificate with the recognized title of “IVDR Specialist”.

What is the IVDR? Why is the regulation important?

The Regulation (EU) 2017/746 on in vitro diagnostic medical devices (Abbreviation IVDR) is the European legislation that regulates market access for in vitro diagnostic medical devices in the European market (CE-marking). European market includes all member states of the European Union plus Norway, Lichtenstein, Iceland and Turkey. IVDR has replaced the previous European legal framework under Directive 98/79/EC on in vitro diagnostic medical devices (IVDD).

IVDR lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices (IVDs) for human use and accessories for such devices in the European Union.Any manufacturer located within the European Union and also outside are responsible for placing of IVDs on the market. Making available on the market or putting into service is the responsibility of the distributors.

IVDR also applies to clinical performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the European Union.

Many but not all of the requirements of the IVDR are analogous to the Medical Device Regulation (EU) 2017/745 (Abbreviation MDR), as the MDR applies specifically to medical devices, while the IVDR applies exclusively to in vitro diagnostic medical devices and corresponding accessories.

Since when does the IVDR apply?

IVDR already entered into force in May 2017 and applies from May 26, 2022.

What are in vitro diagnostic medical devices in contrast to medical devices?

Medical devices (MDs) are products, services or solutions that are used to prevent, diagnose, monitor, treat diseases or alleviate or compensate injuries or disabilities of humans. There are more than 500,000 different medical devices available in hospitals, community care settings and private homes on the European market. These include everyday objects such as adhesive tapes for wound dressing, syringes, surgical masks, latex gloves, as well as spectacles, wheelchairs, infusion pumps, X-ray equipment, catheters, hip implants, pacemakers and medical apps.

In vitro diagnostic medical devices (IVDs) are a special group of medical devices and therefore they have their own legislation.

IVDs are non-invasive tests used on biological samples from the human body (for example blood, urine or tissues) to determine the status of a person’s health.There is a broad range of IVDs, almost 50,000 different products, from self-tests for pregnancy and blood glucose monitoring for diabetics, over near patient tests for COVID-19 in the physician office to sophisticated diagnostics performed in medicinallaboratories (for professional use), such as HIV testing, blood grouping and cancer screening.

The IVD may be a reagent, calibrator, control material, kit, instrument, software or system used in vitro for the examination of human specimens. In vitro diagnostic products for veterinary purposes are not covered by IVDR.

What are the main changes resulting from the IVDR?

The basic approaches of the IVD Directive continue to apply.Although the IVDR further on utilizes the basic approach taken from the IVD Directive, the IVDR introduces important changes as:

• New classification system
• Expansion of scope
• Stricter requirements for economic operators
• Stricter oversight and involvement of notified bodies
• Stricter demands on transparency and traceability (UDI and SRN)
• Stricter Rules on Technical Documentation / Clinical Evidence
• Stricter post-market surveillance requirements

that must be implemented by industry, notified bodies, but alsohealth institutions and competent authorities in the member states.

All in vitro diagnostic medical devices need re-assessment according to the new requirements of IVDR if they are to remain on the market. Beyond the transitional provisions no grandfathering of existing approvals under IVD Directive (98/79/EC) is permitted.

→ There is a need for training among all economic operators.

Who are economic operators?

Economic operators are:

• Manufacturers of IVDs located within the European Union
• Any manufacturer (from a non-EU country) intending to place IVDs on the European market
• Authorized representatives located within the EU (requiredfor manufacturers from a non-EU country)
• Importers within the EU who place IVDs from a third country on the Union market
• Distributors who provide products in the logistics chain within EU

The requirements for all economic operators were regulated more strictly as well as reporting procedures and communication between operators were defined more precisely. IVDR introduced a new role of the person responsible for regulatory compliance (PRRC) in Article 15. Each manufacturer must designate a PRRC, regardless of the location, as well as each authorized representative.

Who else must comply with the IVDR?

In addition to economic operators, health institutions established in the Union are also affected by the new requirements of the IVDR if they manufacture in vitro diagnostic medical devices and use them only within the health institution. The so-called in-house privilege applies to health institutions according to Article 5 (5) IVDR.

Diagnostic service providers from non-EU countries using laboratory derived tests are affected, too, when offering their services on the EU market.

For which group of participants is the training particularly interesting?

• Manufacturers of in vitro diagnostic medical devices all over the world with target market Europe, especially their employees in:
  • Research & Development, Manufacturing and related areas
  • Quality Management / Regulatory Affairs
  • Person responsible for regulatory compliance (PRRC) according to Art. 15 (IVDR)
• EU authorized representatives, importers and distributorswithin EU
• IVD suppliers whose employees cooperate with Companies(target market Europe)
• IVD Consultants
• Diagnostic service providers from non-EU countries using laboratory derived tests, when offering their services on the EU market.
• Health institutions within the EU for which the in-house privilege applies (only some aspects of the training are relevant)

Is prior knowledge required to participate in the training?

The course is suitable for new employees in the field of in vitro diagnostic medical devices who do not have any previous regulatory knowledge.

However, the course is also aimed at experienced staff with a regulatory background in the former legislation who need to build up their knowledge of the IVDR or continuously update.