MDR / IVDR from the perspective of distributors and importers
Customized corporate training for accurate product classification and regulatory compliance
Request a quote
MDR / IVDR from the perspective of distributors and importers
Customized corporate training for accurate product classification and regulatory compliance
Request a quote
Are you an importer or distributor? Find out about your obligations under the MDR and IVDR!
The new legislation on medical devices and in vitro diagnostic medical devices – the MDR and IVDR – impose specific, enforceable obligations not only on manufacturers, but also on distributors and importers. Compliance with these obligations is essential for the lawful functioning of the market, but their practical application raises a number of questions. It is not easy to decide how to divide the responsibilities between economic operators. Then there are the registration obligations – in the case of distributors, we must not forget the NOR database in addition to EUDAMED. For importers, it is also extremely important to maintain contact with the market surveillance authority, keep documents available and check compliance with the legislation. However, we also need answers to a number of other complex questions:
✓ What pre-market control tasks must distributors and importers perform?
✓ What are the recording and information obligations of these actors?
✓ When is an economic operator considered a distributor, an importer or a manufacturer?
✓ How does the legislation relate to service materials and warranty servicing?
✓ What special obligations apply to importers under the labelling, conformity and notification rules?
We can help you answer all these questions!
Details
✓ Customised topics based on preliminary needs assessment
We thoroughly assess your company’s needs prior to the training. Our company has a set of basic topics that we tailor to your needs and organisational characteristics!
✓ Fast, flexible implementation
We also tailor the training format to your company’s needs: we offer online or face-to-face training, half-day, one-day or multi-day courses.
✓ Expert trainer(s) and exclusive training materials
We provide experienced trainers who teach in a clear and practical manner. We provide customised training materials in both printed and digital formats.
✓ Certificate – for participants and the company
At the end of the training, we assess how useful the knowledge imparted has been and provide feedback on any areas for further improvement.
The individual certificates for participants contain the individual results of the online test taken by employees who have completed the training.
The company certificate contains the details of the training (duration, topics, method) as well as the overall results of the participants.
✓ Distributors of MD and IVD devices
✓ Importers of MD and IVD devices
NoBoVersum Zrt. has a basic curriculum and related training materials that we tailor to your needs and organisational characteristics!
Our starting point, the basic curriculum:
- A few words about the regulatory environment, with particular regard to deadlines affecting economic operators
- Distinction between economic operators: distributor, importer, manufacturer and authorised representative – legal and practical boundaries
- Classification and related interpretations
- The concept of medical devices in the MDR and IVDR
- Clarification of service issues
- Registration obligations – national (OGYÉI-NOR) and EU (EUDAMED) obligations, importer notifications
- Pre-market checks (CE marking, label, instructions for use (IFU), documents of conformity, importer details). UDI (Unique Device Identifier)
- Description of registration requirements (customer complaints, side effects, incidents, non-compliant devices, recalled and withdrawn devices)
- Description of information and product conformity requirements – the role and responsibility of importers in checking the conformity of devices
- Vigilance
Course ID: 5000