Webinar: Consultation procedure and borderline products

In our free webinar, Dr. Eric Sasko will provide practical insights into the MDR's regulatory requirements and explain common pitfalls that manufacturers face in their day-to-day operations. Take this opportunity to engage with Dr. Sasko directly and ask questions.

In the webinar, you’ll learn:

• Which products can be classified as borderline, combination, or substance-based
• The significance of MDR classification rules 14 and 21
• Gray areas, red flags, common fallacies, and "real-world cases"/examples
• What requirements apply to combination products under Annex IX 5.2
• What requirements must be considered for substance-based products under Annex IX 5.4
• The complete medicinal product consultation process under Annex IX 5.2 for Type 1(8) products

This webinar is designed for medical device industry professionals and executives who deal with regulatory requirements, product classification, and conformity assessment procedures.

It is particularly suitable for:

• Medical device manufacturers
• Quality managers
• Regulatory affairs managers
• Clinical specialists
• Those responsible for market authorization and conformity assessment

Borderline products are those for which it is unclear whether they are medical devices or medicinal products. This occurs when their intended use falls within a broader area between regulatory frameworks. Correct classification is crucial because it determines the applicable regulatory requirements, conformity assessment procedure, and market access. Incorrect classification can lead to delays in the approval or certification process.

To help manufacturers distinguish the classification of their products, the European Commission established the Manual on Classification and Borderline Products in accordance with the Regulations MDR (EU) 2017/745 (MDR) and IVDR (EU) 2017/746. The manual provides practical examples and common interpretations to help manufacturers with the regulatory assessment of complex products and borderline cases.

It is important to note that a product cannot be placed on the market as both a medical device and a medicinal product simultaneously.

If there are reasonable doubts about its classification, and it could fall under both medicinal product and medical device regulations, the “doubt rule” generally applies and it is considered a medicinal product.

The consultation procedure involves a panel of experts evaluating certain medical devices. It is intended to provide an additional assessment of products that pose specific risks or have complex characteristics, or both.  Article 52(9) establishes the procedure outlined in Annex IX, Section 5.2, for combination products, as defined in Article 1(8). This section governs the consultation procedure for medical devices that incorporate a medicinal product. It requires Notified Bodies to obtain a binding scientific opinion from the European Medicines Agency (EMA) or a national drug regulatory authority (e.g., the Federal Institute for Drugs and Medical Devices [BfArM]) before authorizing a medical device that incorporates a medicinal product. The relevant authority must issue this opinion within 210 days.

• Class III implantable devices;
• Class IIb active devices that administer or remove medicinal products from the body in accordance with Annex VIII, Section 6.4 (Rule 12).

Conducting a consultation procedure may affect the process and duration of the conformity assessment. Therefore, it is important for manufacturers to determine early on whether their product is subject to these requirements and what documentation is needed.