1. 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.
2. 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.

• 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.

• 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.

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)

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 €3316 per person

Supplementary Module Fees* (at least one mandatory):

• Site Auditor: Instead of €2300 per person € 2185 per person
• Product Reviewer: Instead of €2300 per person €2185 per person
• Clinical Expert: Instead of €2300 per person €2185 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:

1. 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! 

2. 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.

✔ It goes beyond theory — delivering real, applicable expertise
In just 10 months, you’ll gain the full set of competences required for MDR conformity assessment specialists. You’ll master every key topic — from risk-based classification and clinical evaluation to technical documentation, conformity procedures, and the roles of notified bodies and manufacturers. This is the level of depth today’s medtech market demands.

✔ It’s adaptive and personalised to your knowledge level
Our platform’s unique adaptive learning system ensures that you only spend time on what you really need. Through interactive online quizzes — our so-called learning molecules — the system identifies which areas you already master and adapts the learning path accordingly. It saves time and keeps your progress efficient and focused.

✔ It’s built on an innovative molecular educational method
The molecular learning approach breaks complex MDR knowledge into small, logically connected “molecules” — concise, understandable learning units. This helps you grasp the logic behind MDR requirements and makes it easier to learn even when balancing the course with a full-time job.

✔ It’s flexible — but always personal
Designed for working professionals, this training can be completed alongside a full-time job. You can study at your own pace through our e-learning platform, while monthly interactive workshops and weekly live consultations provide real-time guidance, feedback, and professional connection. It’s a flexible structure — but with personal support every step of the way.

✔ It’s officially licensed, validated, and recognised for its quality
Developed under Hungary’s official adult education licence (E/2023/000048) and validated by accredited experts, the programme meets strict state and professional standards. Upon completion, you’ll receive a professionally validated certificate — proof of competence and your entry into a growing MDR expert community.

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.