Medicine, device or other product?
Customized corporate training on correct classification of borderline products and devices containing medicinal substances
Request a quote
Medicine, device or other product?
Customized corporate training on correct classification of borderline products and devices containing medicinal substances
Request a quote
The question ‘Is it a medicine, a device or another product?’ is not a theoretical brainteaser – it is a serious business decision!
Deciding whether a product is a medicine, a medical device or another product is not at all obvious. What is more, an incorrect product classification can have serious consequences, such as withdrawal from the market or even the failure of the entire project.
That is why we are now offering training courses that provide a comprehensive overview of the requirements for the classification, documentation and regulatory approval of borderline products, as well as the requirements for medical devices containing medicinal products or other materials. Participants will gain up-to-date knowledge of the relevant guidelines and recommendations and how to develop a corresponding strategy.
Why Choose Us?
✓ Customised topics based on preliminary needs assessment
We thoroughly assess your company’s needs before the training. Our company has a set of basic topics that we tailor to the specific characteristics of your organisation!
✓ 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 form.
✓ 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 organisation certificate contains the details of the training (duration, topics, method) as well as the overall results of the participants.
To Whom Do We Reccomend the Training?
If you are interested in borderline products:
✓ Quality assurance professionals responsible for developing a classification strategy for products that are already on the market but have changed, preparing MDR documentation and communicating with authorities
✓ Clinical, toxicological and biocompatibility assessment experts involved in the clinical and toxicological evaluation of borderline products
If you are interested in devices containing medicinal substances:
✓ Manufacturers and developers who incorporate active substances, antibacterial ingredients or other medicinal materials into their medical devices
✓ Pharmaceutical development teams involved in the development of devices with combined or complementary effects
Details
- What does it mean when a device is ‘borderline’?
Borderline devices are products whose classification is unclear between the regulatory categories of medical devices and medicinal products. These products must comply with different regulatory requirements and therefore require special expert assessment for correct classification.
- Why is correct classification important under the MDR?
The correct classification of a product determines the applicable regulations, the type of conformity assessment procedures, the organisations and authorities to be involved (e.g. Notified Body, EMA) and the documentation requirements. Incorrect classification can lead to legal and market risks.
- Does the training help to decide whether a product is a device or a medicine?
Yes The training presents the relevant legislation, regulatory guidance and analysis methods that can be used to make a professionally sound decision on the correct classification. In addition, specific case studies provide insight into borderline situations that arise in practice.
- When is a medicinal product considered to have an ancillary effect under the MDR?
When the device contains a medicinal product or a substance derived from human blood or tissue that exerts an ancillary effect in the body, but the primary function of the device remains physical or mechanical. The MDR lays down specific requirements for these products.
- What are some examples of devices containing medicinal substances?
Examples include antibiotic-releasing dressings, drug-eluting implants or catheters coated with anticoagulants. In these cases, it is crucial to analyse the role of the active substance, i.e. whether it is ancillary or primary.
Our starting point, the basic curriculum:
Introduction to the regulatory environment for product classification
- The role of classification in the conformity strategy
- Legal background: MDR, IVDR, Directive 2001/83/EC
- The concept of borderline in legislation and practice
- Consequences of incorrect classification: certification, market entry, legal risks
Classification dilemmas
- Primary vs. ancillary effect: practical analyses
- Common defects and misunderstandings in industry practice (e.g. cosmetics, pharmaceuticals, biocidal products?)
- Guidance from European Commission working groups (the so-called ‘Borderline List’)
- Related MDCG guidance (e.g. MDCG 2024-13, 2022-5, 2021-24)
Our starting point, the basic curriculum:
- Practical application of MDR Article 1(8) and Article 117
- Related annexes to the MDR (special rules for classification)
- Definition of terms
- Examples of Notified Body comments and certification refusals
- Role of the scientific opinion of the European Medicines Agency (EMA)
- Authority practice in the EU (EMA, national authorities, Notified Bodies)
- When is the involvement of the EMA mandatory?
Article ID: 5005
Form of training: training is provided at the headquarters/premises of the contracting authority or online, in accordance with the contracting authority’s request.
The advantage of on-site training is that our expert trainers will provide exactly the knowledge that the company requesting the quote really needs. Participants in the training receive personalised answers to each question, making this form of training an extremely effective forum for brainstorming and exchanging experiences.
NOBOVERSUM undertakes the following tasks:
- compiles the proposed topics based on the requirements of the contracting authority and provides expert lecturers;
- providing the training materials in electronic and printed form;
- ensuring that the lecturers answer all questions asked by the participants.