The distinction between medical devices and drugs may seem clear, but there are areas of intersection where boundaries become blurred. Products such as drug delivery systems, which combine both aspects, require a deep understanding of the regulations for both categories. This short guide will explore these intersections and offer tips for ensuring compliance.
1. Medical devices vs drugs: a fundamental distinction
Before diving into areas of overlap, it is vital to understand the main differences between medical devices and drugs in terms of definition, function, and regulation.
2. When the device meets the drug
There are products, such as drug delivery systems or implantable drug-delivery devices, that combine the characteristics of both categories. As a result, their regulation becomes more complex.
3. The combined regulatory framework
Italy, in line with the European Union, has specific guidelines for products combining medical devices and drugs. It is essential for companies to understand these regulations to ensure full compliance.
4. Challenges in clinical trials
The testing of combination products poses unique challenges. They may require clinical studies that consider both the appearance of the device and the pharmacological aspect, complicating the approval process.
5. Best practices for compliance
Companies should consider:
- Specific training for the regulatory team on combination products.
- Close collaboration between medical device and pharmaceutical experts within the company.
- An early consultation with regulatory authorities to better understand expectations and potential challenges.
While the interaction between medical devices and drugs offers innovative opportunities in the field of patient care, it also brings with it several regulatory challenges. With proper preparation and a clear understanding of regulations, companies can successfully navigate this complex territory.
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