MDR / IVDR from the Distributor’s Perspective
MDR / IVDR from the Distributor’s Perspective
Current Relevance
The new regulations for medical devices and in vitro diagnostic medical devices – MDR and IVDR – impose numerous obligations on distributors. Even determining what qualifies as a medical device and distinguishing it from a drug or a technical care device can be challenging. Then come the registration requirements; for distributors, it is important to not only consider EUDAMED but also the NOR database. Additionally, several other complex questions need to be addressed, such as:
- What pre-market control tasks must distributors perform?
- What record-keeping and reporting obligations does the distributor have?
- When is an economic operator considered a distributor, and when a manufacturer?
- Which devices are classified as so-called legacy devices?
- How does the regulation view service materials and warranty servicing?
Details
Technical Information
Item Number: 5000
Training Format: The training takes place at the requester’s headquarters/other location or online, as requested.
The advantage of an external training session is that our expert instructors will provide exactly the knowledge the requesting company truly needs. Participants will receive tailored answers to every question, making this training format an extremely effective forum for collaborative thinking and knowledge sharing.
NOBOVERSUM undertakes the following tasks:
- Compiles a recommended syllabus based on the requester’s needs and provides expert instructors.
- Provides the presentation materials in electronic format.
- Ensures that instructors answer all the questions posed by participants.
Our instructors:
- Attila Juhász, Professional Lead SAASCO Consulting and Engineering Office Ltd.
To whom do we recommend the training
Distributors of medical devices
Curriculum and Duration
Curriculum:
- Brief overview of the regulatory environment, with a focus on deadlines affecting economic operators.
- Distinguishing distributors from other economic operators. When is an economic operator considered a distributor and when a manufacturer?
- Classification of devices and related interpretations.
- Definition of a medical device under MDR and IVDR.
- Clarification of service-related issues.
- Overview of registration requirements, distinguishing between national (OGYÉI-NOR) and international (EUDAMED) product registrations, and related obligations and deadlines.
- Pre-market checks (CE marking, label, user manual, compliance documents, importer information). Unique Device Identifier (UDI).
- Overview of record-keeping requirements (customer complaints, side effects, unexpected events, non-compliant devices, recalled and withdrawn devices).
- Overview of reporting and product compliance requirements.
- Vigilance system.
Duration:
Half-day training (240 minutes in total).