04 Mar What are Combination Products, we explain these complex healthcare products.
Our Operations Director, Sandra Javaloyas, has published, in the February 2022 issue of Farmespaña Industrial magazine, an article about what Combination Products are and what regulation affects them.
The regulation of Combined Products can be very complicated and sometimes help is needed to understand them as simply as possible.
Combination Products. What are they?
These are medical devices that achieve their intended use through the incorporation of a medicinal product or substance.
An example of such a product is an insulin pump: an insulin pump delivers insulin through a plastic tube or catheter. The device can pump insulin continuously or more rapidly before meals, called a bolus. It is a combination product as it does not achieve its intended use without the necessary insulin (substance).
How are Combined Products regulated?
Such products are regulatedby the Medical Devices Regulation, MDR 2017/745, or by Directive 2001/83/EC. In determining the applicable regulation in each case, the action of the medicinal product or substance in the product must be taken into account. If this action is ancillary, the combined product will be regulated by MDR 2017/745. The procedures of both regulations do not apply cumulatively.
The marking procedure for Combination Products is similar to that of any other medical device. The manufacturer must compile and prepare the technical documentation in accordance with current regulations and, depending on the risk classification of the product, the product must be approved by a notified body.
At Episkey Medical Consulting, we continue to support medical device manufacturers to help them understand what type of product they manufacture and what regulation affects them.