I want to manufacture or import a product, but… is it a medical device? Or is it an in vitro diagnostic medical device?
Determining whether a specific product falls within the definition of a medical device (in accordance with Article 2 of the MDR, Regulation 2017/745, and the IVDR, Regulation 2017/746) and applying the classification rules are the responsibility of the manufacturer and of the authorities of the Member States where the product is on the market (in Spain, the AEMPS).
The aspects relating to the boundary between medical devices and other types of products, also known as the qualification of a product, are generally governed by Article 4 (Regulatory status of products) of the MDR and the corresponding Article 3 of the IVDR. “Borderline” cases are those in which it is not clear from the outset whether a given product is a medical device or an in vitro diagnostic medical device (IVD), or not. Several paragraphs of Article 1 (Subject matter and scope of both Regulations) are also relevant. They exclude certain types of products from the scope of the Regulation. Where a given product does not fall within the definition of a medical device or is excluded from its scope, other EU or national legislation may be applicable.
For these “borderline” cases, updates of the borderline manual on medical devices, are posted on the official website of the European Commission in its public health section, presenting an update of the products under study and the opinion reached on each of them.
The following questions may serve as guidance for the qualification of the product:
<img width="800" height="646" src="../../images/blog/es-un-producto-sanitario_producto-sanitario.png-1500x1211-1-1024x827.webp" alt="" loading="lazy" srcset="https://i0.wp.com/medev.es/wp-content/uploads/2023/03/es-un-producto-sanitario_producto-sanitario.png-1500x1211-1.jpg?resize=1024%2C827&ssl=1 1024w, https://i0.wp.com/medev.es/wp-content/uploads/2023/03/es-un-producto-sanitario_producto-sanitario.png-1500x1211-1.jpg?resize=300%2C242&ssl=1 300w, https://i0.wp.com/medev.es/wp-content/uploads/2023/03/es-un-producto-sanitario_producto-sanitario.png-1500x1211-1.jpg?resize=768%2C620&ssl=1 768w, https://i0.wp.com/medev.es/wp-content/uploads/2023/03/es-un-producto-sanitario_producto-sanitario.png-1500x1211-1.jpg?w=1500&ssl=1 1500w" sizes="(max-width: 800px) 100vw, 800px" />
IT IS A MEDICAL DEVICE, BUT WHAT IS ITS CLASSIFICATION?
Once a product qualifies as a medical device, it will be assigned a specific risk class: Class I, IIa, IIb, III.
For a product qualified as an IVD, the risk classes are: Class A, B, C, D.
The aspects relating to the classification of a medical device are governed by Article 51 of the MDR (Classification of devices) and Annex VIII (Classification rules). For the IVDR, the corresponding references are Article 47 and Annex VIII.
BOUNDARY BETWEEN MEDICAL DEVICES AND OTHER TYPES OF PRODUCTS
The different classes of products must be distinguished:
- Boundary between medical devices and medicinal products.
- Boundary between medical devices and biocides.
- Boundary between medical devices and cosmetics.
- Boundary between medical devices and PPE (personal protective equipment