Smart drugs: Drugs or Medical Devices?

Software is on the rise when it comes to the implementation in health care; from the application of VR, AR and AI technology to health tracking apps and the ability to monitor patients at a distance. The European Medicine Association (‘EMA’) predicts that they will be seeing increasingly more drug-device combination products. But how are these products regulated? As a medical device or as a drug?

It goes without saying that software in itself is increasingly being classified as a medical device. Software is, however, also making an entrance in drug-device combination products. Are we talking about drugs or medical devices here?

What is a combination product?

The combination between a drug and a medical device, is being called a ‘combination product’. Traditional combination products are, for example, catheters with an antimicrobial coating. With regards to software, there are drugs with build in sensors (the so-called ‘smart drugs’) and, the other way around, sensors that contain a drug (for example, smart inhalers).

How are combination products regulated?

Traditionally, a Notified Body (‘NB’) is involved in the market access for software as a medical device and the EMA in the market access for drugs. Considering combination products, the EMA makes a distinction between integral combination products and co-packaged combination products.

Co-packaged combination products are made up of two or more separate components (for example a drug and a medical device) which are not integrated during manufacturing, but are intended to be integrated for administering. The stand-alone medical device will be regulated accordingly.

An integral combination product is a product that incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product (Article 1(8), MDR). As integrale combination products are also products considered that are aimed for administering a medicinal product in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable (Article 1(9), MDR). This is, for example, a pre-filled disposable insulin pen, which forms one integrale product with the filling and is for single use. 

If the intended purpose of the integrale combination product is achieved by the drug, the entire product is regulated as a drug. Nonetheless, we want to be able to check whether the resource part is safe and effective. 

How are combination products regulated under the EU MDR?

With the MDR coming into force at in May 2021, the successor to the Medical Device Directive, requires demonstrating compliance with the General Safety and Performance Requirements (‘GDPRs’) for integral combination products. What does this mean in practice? 

When applying for market authorization (the Marketing Authorization Application) to the EMA, manufacturers of integral combination products must be able to demonstrate that the device part of the product complies with MDR’s GSPRs. This can be demonstrated by submitting a CE certificate or EU declaration of conformity from the manufacturer. 

When the device part does not have a CE marking, but should have one if it were to be offered on the market as a separate product, then an opinion from the NB stating that the device part of the product complies with the GSPRs is sufficient. This applies to products with a risk class of IIa or higher. To avoid additional work, the EMA provides an template for this advice. 

In summary, we can state that the GSPRs, as described in Appendix 1 of the MDR, will apply even more widely after May 26th, 2021. 

Read the full dutch article here.