IVDR Medical Device Conformity Assessment Training
Practice-Oriented Training for Manufacturers, PRRCs and Future Site Auditors, Product Reviewers, Clinical Experts
Course Duration:
Site Auditor Group: 30 Jan 2026 – 26 Nov 2026
Product Reviewer Group: 30 Jan 2026 – 27 Nov 2026
Clinical Expert Group: 30 Jan 2026 – 25 Nov 2026
The exact dates of the practical group projects can be found in the description of the supplementary modules.
Course Fee:
See Details
15% Early Bird discount until 31 October 2025.
IVDR: Understanding is not enough. Apply It!
It’s a fact that the new EU regulation on in vitro diagnostic medical devices (IVDR) has introduced numerous strict requirements, posing significant challenges for manufacturers and notified bodies alike. At the same time, the regulation has drastically increased the demand for experts in conformity assessment.
Here are just a few of the key changes introduced by IVDR:
- The stricter, risk-based classification system has placed many more products under the supervision of notified bodies (NOBOs).
- Manufacturers now face increased requirements for post-market surveillance systems.
- There are stricter requirements for manufacturers regarding performance evaluation and performance studies.
- The introduction of Unique Device Identification (UDI) and the mandatory use of EUDAMED add extra administrative tasks.
- Every manufacturer must appoint a Person Responsible for Regulatory Compliance (PRRC).
And these are just the most critical changes! Once you understand the new regulations, the next challenge is interpreting and applying them in practice.
If you’re a manufacturer looking to ensure compliance with IVDR in real-world scenarios, or if you’re considering a career in a notified body, our latest training is designed just for you!
Details
- This training is recommended for those considering a career as a medical device certifier within a notified body. Through our program, participants can gain insights into the intricacies of a highly sought-after and respected profession.
- The training is also recommended for medical device manufacturers who want to understand what to expect during the certification process and how to prepare effectively for such an audit.
Attention! Joining the training does require having a tertiary degree, but does not require meeting the other conditions specified in the tables below. However, notified bodies may require the fulfilment of these conditions or set additional requirements, and ultimately, the candidate must comply with these.
- The main task of a site auditor is to carry out audits of the manufacturer’s quality management system at the site of the manufacturing company. This includes conducting interviews with the manufacturer’s employees and inspecting various processes.
| REQUIREMENTS FOR BECOMING A SITE AUDITOR (IVDR Annex VII, Section 3.2.6) | |
| Required qualification: | Required Professional Experience: |
| Relevant university or technical college degree (e.g., in medical, pharmaceutical, engineering, or other relevant fields) or equivalent qualification. | 4 years of professional experience in the field of healthcare products or related activities (e.g., manufacturing, auditing, or research), including 2 years in quality management. |
- A product reviewer is responsible for reviewing the medical device itself. This primarily involves assessing whether the product’s technical documentation complies with legal and standard requirements.
| REQUIREMENTS FOR BECOMING A PRODUCT REVIEWER (IVDR Annex VII, Section 3.2.5) | |
| Required qualification: | Required Professional Experience: |
| Relevant university or technical college degree (e.g., in medical, pharmaceutical, engineering, or other relevant fields) or equivalent qualification. | 4 years of professional experience in the field of healthcare products or related activities (e.g., manufacturing, auditing, or research), including at least 2 years in the design, development, testing, or use of medical devices, or in the relevant technology or scientific aspects being evaluated. |
- A clinical expert evaluates the product’s compliance from a clinical perspective. This includes reviewing clinical evaluations conducted by the manufacturer and examining data from any clinical trials.
| REQUIREMENTS FOR BECOMING A CLINICAL EXPERT (IVDR Annex VII and NBOG’s BPG 2017-2, Section 5.4) | |
| Required qualification: | Required Professional Experience: |
| The IVDR does not specify exact qualifications. However, the related Guide (NBOG 2017-2) generally expects a medical qualification. | The IVDR does not specify exact professional experience. However, the related Guide (NBOG 2017-2) generally expects a medical qualification. The MDR/IVDR does not specify the necessary professional experience either. According to the related Guide (NBOG 2017-2), the following is required:
|
Duration: 10 months
The training is on break during July and August.
Participants still have access to the e-learning materials during this period.
Dates:
- Core Module + Site Auditor Supplementary Module: 30 January, 2026 (Friday) – 26 November, 2026 (Thursday)
- Core Module + Product Reviewer Supplementary Module: 30 January, 2026 (Friday) – 27 November, 2026 (Friday)
- Core Module + Clinical Expert Supplementary Module: 30 January, 2026 (Friday) – 25 November, 2026 (Wednesday)
Application Deadline: 31 December, 2025
Attention! The dates of individual practical project tasks can be found in the descriptions of the supplementary modules. We reserve the right to change the dates.
IVDR Core Module Fee*: Instead of €3490 per person €2990 per person
Supplementary Module Fees* (at least one mandatory):
- Site Auditor: Instead of €2300 per person € 2000 per person
- Product Reviewer: Instead of €2300 per person €2000 per person
- Clinical Expert: Instead of €2300 per person €2000 per person
The module fee includes access to the e-learning platform and mentoring of participants – i.e. professional answers to their questions – throughout the course.
Additional Fee:
- Exam Fee: €290 per person per exam
Covers the cost of the expert instructor-administered exam and evaluation based on personal attendance, as well as the issuance of a certificate upon successful completion.
* The fees for both the core module and the supplementary modules are exempt from VAT based on Section 85 (2) (bb) of Act CXXVII of 2007 on Value Added Tax, as the course is organized under an adult education license.
Item number:9001/01
Training Format: Online training
Training structure:
The IVDR Medical Device Conformity Assessment core module consists of five base subjects, an orientation and the introduction to IVDR.
In addition to the core module, participants can choose from three supplementary modules: Site Auditor, Product Reviewer, or Clinical Expert, with at least one being mandatory.
Instructors:
- Árpád Zsolt Bús (Consultant and Test Engineer, SAASCO Consulting and Engineering Office Ltd.)
- Attila Juhász (Professional Lead, SAASCO Consulting and Engineering Office Ltd.)
- György Balázs (Managing Director, Quality Expert, EMKI-cert Ltd.)
- Katalin Tauberné Jakab, MD. (Clinical Expert, QTICS Medical)
- Mária Kriston (Professional Lead, Site Auditor, NoBoMed Plc.)
- Tímea Markóné Németh (Quality Expert, EMKI-cert Medical Device Certification Ltd.)
The training consists of two main parts:
- THEORETICAL PART – Online Learning via a Modern E-learning Platform
✔ The theoretical knowledge is acquired by participants through smaller digital units, known as learning molecules, which are adaptable to the individual knowledge and learning pace of the participants.
✔ Each molecule is linked to a practical online test, which helps integrate the knowledge into long-term memory.
✔ The e-learning platform allows for adaptive teaching. If a participant already knows a specific topic, they can skip it by successfully completing a short online test. This way, everyone learns only what they truly need!
- PRACTICAL PART –Practical Project Tasks in a Group
✔ During these online sessions, participants work in groups to solve project tasks assigned by an expert mentor.
✔ The mentor continuously supervises and supports the participants’ work: assigns tasks to group members and provides ongoing written consultation opportunities. The participants’ performance is evaluated in a formative manner through continuous feedback integrated into the learning process.
✔ What types of project tasks should be anticipated? Tasks that are commonly encountered in the role of a site auditor, a product reviewer or a clinical expert! For example, a future site auditor will likely need to plan audits, identify so-called non-conformities or prepare various audit reports. Thus, it is understandable that the course will include such project tasks.
✔ Because it provides marketable, practical, and up-to-date knowledge!
Our modern training program was developed in response to the real labour market needs of the medical technology industry. We identified the tasks that future site auditors, product reviewers, and clinical experts will need to perform in their new roles. These activities were then translated into practical project tasks.
✔ Because it is adaptive, catering to participants’ varying qualifications and knowledge levels!
Our goal is for participants not to spend unnecessary time on knowledge they already possess. This is achieved through our platform’s “synthesizing molecules.” These molecules test knowledge in specific areas through an online quiz. If participants successfully complete the quiz, they can skip the corresponding learning modules related to that topic.
✔ Because the molecular educational method helps in understanding logical connections!
The essence of the molecular educational method is to organize theoretical knowledge into the smallest, independently understandable units, known as learning molecules. Participants who are balancing the course with work can more easily find time to master these smaller units. Additionally, logically structured knowledge molecules aid in understanding more complex connections.
✔ Because it can be completed alongside work!
A modern adult education program must be feasible alongside a full-time job. An online training format offers the flexibility for participants to progress through the material at their own pace and according to their own schedule.
✔ Because we focus on skill development rather than just knowledge transfer!
Participants must collaboratively solve and present practical project tasks to mentors. This process helps in developing various skills, such as teamwork, problem-solving, and communication.
The certificate issued by NoBoVersum verifies that the participant who successfully completes the training possesses all the knowledge required by Regulation (EU) 2017/746 of the European Parliament and of the Council (IVDR) for site auditors, product reviewers, or clinical experts of notified bodies. The certificate includes a detailed list of the theoretical subjects and their durations, as well as the practical project tasks.
Training Structure
I. Core Module (for all participants)
- General Knowledge of IVDR (Subject Code: IB001, Author: Attila Juhász)
- Performance Evaluation of IVD Medical Devices (Subject Code: IB002, Author: Dr. Katalin Tauberné Jakab)
- IVDR General Safety and Performance Requirements– GSPR (Subject Code: IB003, Author: Dr. Katalin Tauberné Jakab)
- IVDR Conformity Assessment Procedures (Subject Code: CB001/IVDR, Author: Attila Juhász)
- Basics of Risk Management (Subject Code: CB002, Author: Attila Juhász)
- Introduction to the training goals, educational methodology, and use of the e-learning platform.
- Date: 30 January, 2026 (Friday)
- An overview of the main objectives, structure, and key concepts of the In Vitro Medical Devices Diagnostic Regulation (IVDR).
- Date: 13 March, 2026 (Friday)
II. Supplementary Modules (required to choose at least one)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for site auditors
- Design for Good Usability (Subject Code: CR001, Author: Attila Juhász)
- Quality Management Systems and Auditing Techniques (Subject Code: CR002, Author: Attila Juhász)
- Validation (Subject Code: MR003, Authors: Mária Kriston, Róbert Heck, György Balázs)
- Communication (Subject Code: MR004)
PRACTICAL PART (group projects under expert mentorship)
Project 1: Review of Manufacturer’s Documents and Preparing an Audit Plan
- The aim of the project is for the participant to critically review the quality management documentation submitted by the manufacturer. By the end of the project, the participant will be able to independently plan on-site audits based on the manufacturer’s quality management documents.
- Date: 16 April, 2026 (Thursday)
Project 2: Evaluation of the Manufacturer’s Quality Management Documentation
- By the end of the project, the participant will be capable of critically reviewing and evaluating the manufacturer’s submitted documentation and determining whether the client is ready for an on-site audit.
- Date: 21 May, 2026 (Thursday)
Project 3: Nonconformity Report
- By the end of the project, the participant will be able to independently record nonconformities identified during on-site audits.
- Date: 11 June, 2026 (Thursday)
Project 4: Preparing an Audit Report I
- By the end of the project, the participant will be able to process, evaluate, and document the findings gathered during an audit.
- Date: 24 September, 2026 (Thursday)
Project 5: Preparing an Audit Report II
- By the end of the project, the participant will be able to process, evaluate, and document the findings gathered during an audit.
- Date: 29 October, 2026 (Thursday)
ONLINE EXAM
Date: 26 November, 2026 (Thursday)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for product reviewers
- Clinical Evaluation of IVD Medical Devices (Subject Code: IR001, Author: Dr. Katalin Tauberné Jakab)
- IVDR Technical Documentation Assessment (Subject Code: IR002, Author: Tímea Markóné Németh)
- Design for Good Usability (Subject Code: CR001, Author: Attila Juhász)
- Validation (Subject Code: MR003, Authors: Mária Kriston, Róbert Heck, György Balázs)
PRACTICAL PART (group projects under expert mentorship)
Project 1: Preparing of Technical Documentation and GSPR Checklist
- By the end of the project, the participant will be able to identify relevant regulatory requirements and compile a report on general safety and performance requirements (GSPR), gathering and organizing the necessary information based on key criteria.
- Date: 17 April, 2026 (Friday)
Project 2: Evaluation of Manufacturer-Provided Documents
- By the end of the project, the participant will be able to critically evaluate the documents provided by the manufacturer.
- Date: 15 May, 2026 (Friday)
Project 3: Preparing Risk Evaluation
- By the end of the project, the participant will be able to process and synthesize legal requirements and critically evaluate the risk management documentation.
- Date: 12 June, 2026 (Friday)
Project 4: Assessment of Technical Documentation I
- By the end of the project, the participant will be able to critically assess technical documentation.
- Date: 25 September, 2026 (Friday)
Project 5: Assessment of Technical Documentation II
- By the end of the project, the participant will be able to critically assess technical documentation.
- Date: 30 October, 2026 (Friday)
ONLINE EXAM
Date: 27 November, 2026 (Friday)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for clinical experts
- Clinical Evaluation of IVD Medical Devices (Subject Code: MR001, Author: Dr. Katalin Tauberné Jakab)
PRACTICAL PART (group projects under expert mentorship)
Project 1: Planning Performance Evaluation Based on Regulatory Requirements
- By the end of the project, the participant will be able to identify and summarize the requirements for performance evaluation based on IVDR and other relevant regulations.
- Date: 15 April, 2026 (Wednesday)
Project 2: Scientific Literature Search
- By the end of the project, the participant will be able to efficiently collect and assess relevant documentation and literature for clinical evaluation, ensuring reliability and legal compliance. They will also be capable of critically analyzing the statistical and methodological aspects of the filtered literature and evaluating the validity of its conclusions.
- Date: 13 May, 2026 (Wednesday)
Project 3: Designing a Performance Study
- By the end of the project, the participant will be able to design a clinical study, including developing the study protocol, defining the experimental design, and determining the resources and methods necessary for conducting the study.
- Date: 10 June 2026 (Wednesday)
Project 4: Preparing Performance Evaluation Report (PER)
- By the end of the project, the participant will be able to execute a performance evaluation based on the defined plan and methodology, including data collection, analysis, and interpretation in compliance with regulatory requirements.
- Date: 23 September 2026 (Wednesday)
Project 5: Preparing Performance Evaluation Assessment Report (PEAR)
- By the end of the project, the participant will be able to prepare a performance evaluation review report in accordance with the relevant MDCG (Medical Device Coordination Group) guidance, ensuring the report’s completeness and regulatory compliance.
- Date: 28 October 2026 (Wednesday)
Online Exam:
Date: 25 November 2026 (Wednesday)
II. Supplementary Modules (required to choose at least one)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for site auditors
- Design for Good Usability (Subject Code: CR001, Author: Attila Juhász)
- Quality Management Systems and Auditing Techniques (Subject Code: CR002, Author: Attila Juhász)
- Validation (Subject Code: MR003, Authors: Mária Kriston, Róbert Heck, György Balázs)
- Communication (Subject Code: MR004, Author: Judit Kántor)
PRACTICAL PART (group projects under expert mentorship)
Project 1: Review of Manufacturer’s Documents and Preparing an Audit Plan
- The aim of the project is for the participant to critically review the quality management documentation submitted by the manufacturer. By the end of the project, the participant will be able to independently plan on-site audits based on the manufacturer’s quality management documents.
- Date: 16 April, 2026 (Thursday)
Project 2: Evaluation of the Manufacturer’s Quality Management Documentation
- By the end of the project, the participant will be capable of critically reviewing and evaluating the manufacturer’s submitted documentation and determining whether the client is ready for an on-site audit.
- Date: 21 May, 2026 (Thursday)
Project 3: Nonconformity Report
- By the end of the project, the participant will be able to independently record nonconformities identified during on-site audits.
- Date: 11 June, 2026 (Thursday)
Project 4: Preparing an Audit Report I
- By the end of the project, the participant will be able to process, evaluate, and document the findings gathered during an audit.
- Date: 24 September, 2026 (Thursday)
Project 5: Preparing an Audit Report II
- By the end of the project, the participant will be able to process, evaluate, and document the findings gathered during an audit.
- Date: 29 October, 2026 (Thursday)
ONLINE EXAM
Date: 26 November, 2026 (Thursday)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for product reviewers
- Clinical Evaluation of IVD Medical Devices (Subject Code: IR001, Author: Dr. Katalin Tauberné Jakab)
- IVDR Technical Documentation Assessment (Subject Code: IR002, Author: Tímea Markóné Németh)
- Design for Good Usability (Subject Code: CR001, Author: Attila Juhász)
- Validation (Subject Code: MR003, Authors: Mária Kriston, Róbert Heck, György Balázs)
PRACTICAL PART (group projects under expert mentorship)
Project 1: Preparing of Technical Documentation and GSPR Checklist
- By the end of the project, the participant will be able to identify relevant regulatory requirements and compile a report on general safety and performance requirements (GSPR), gathering and organizing the necessary information based on key criteria.
- Date: 17 April, 2026 (Friday)
Project 2: Evaluation of Manufacturer-Provided Documents
- By the end of the project, the participant will be able to critically evaluate the documents provided by the manufacturer.
- Date: 15 May, 2026 (Friday)
Project 3: Preparing Risk Evaluation
- By the end of the project, the participant will be able to process and synthesize legal requirements and critically evaluate the risk management documentation.
- Date: 12 June, 2026 (Friday)
Project 4: Assessment of Technical Documentation I
- By the end of the project, the participant will be able to critically assess technical documentation.
- Date: 25 September, 2026 (Friday)
Project 5: Assessment of Technical Documentation II
- By the end of the project, the participant will be able to critically assess technical documentation.
- Date: 30 October, 2026 (Friday)
ONLINE EXAM
Date: 27 November, 2026 (Friday)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for clinical experts
Clinical Evaluation of IVD Medical Devices (Subject Code: MR001 Author: Dr. Katalin Tauberné Jakab)
PRACTICAL PART (group projects under expert mentorship)
Project 1: Planning Performance Evaluation Based on Regulatory Requirements
- Objective: By the end of the project, the participant will be able to identify and summarize the requirements for performance evaluation based on IVDR and other relevant regulations.
- Date: 15 April, 2026 (Wednesday)
Project 2: Scientific Literature Search
- By the end of the project, the participant will be able to efficiently collect and assess relevant documentation and literature for clinical evaluation, ensuring reliability and legal compliance. They will also be capable of critically analyzing the statistical and methodological aspects of the filtered literature and evaluating the validity of its conclusions.
- Date: 13 May, 2026 (Wednesday)
Project 3: Designing a Performance Study
- By the end of the project, the participant will be able to design a clinical study, including developing the study protocol, defining the experimental design, and determining the resources and methods necessary for conducting the study.
- Date: 10 June 2026 (Wednesday)
Project 4: Preparing Performance Evaluation Report (PER)
- By the end of the project, the participant will be able to execute a performance evaluation based on the defined plan and methodology, including data collection, analysis, and interpretation in compliance with regulatory requirements.
- Date: 23 September 2026 (Wednesday)
Project 5: Preparing Performance Evaluation Assessment Report (PEAR)
- By the end of the project, the participant will be able to prepare a performance evaluation review report in accordance with the relevant MDCG (Medical Device Coordination Group) guidance, ensuring the report’s completeness and regulatory compliance.
- Date: 28 October 2026 (Wednesday)
Online Exam:
Date: 25 November 2026 (Wednesday)
The training is being implemented with the support of the Hungarian Ministry of National Economy, within the framework of the Support Certificate with the identification number “ÁFF/2107/2021-ITM”.