Systems and treatment units

In our day-to-day regulatory work and product registrations, we are often asked about the regulatory details of treatment units . 

What needs to be considered and what is a treatment unit?

According to Article 22 of the European Medical Device Regulation (MDR) , it is possible to combine products that are already CE-marked and place them on the market in the form of systems and treatment units (also known as sets) , e.g. a laser device with matching laser fibers. 

These are usually combinations of products packaged together or separately, which are to be placed on the market together or combined together to fulfill a specific medical purpose. This is straightforward as long as the combined products are used within the intended use restrictions specified by the manufacturer. 

In short, if you pack CE-marked devices together, which are used together according to their intended purpose, then you can place them on the market as a third party without having to go through another conformity assessment procedure.
In these cases, the sets are not provided with an additional CE marking marking. 

The following steps are required for this:

1. Registration as a manufacturer of systems and treatment units (System/procedure pack producer, PR) 
2. Ensuring the existing CE marking of the products to be combined
3. Ensuring use in accordance with the manufacturer's intended purpose
4. Ensuring that all necessary user instructions are part of the set
5. Marking the system or treatment center with your trade name/registered trademark and address 
6. Vergabe einer Basis UDI-DI
7. Labeling of the set with a UDI carrier
8. Preparation and storage of a short declaration in accordance with Article 22, MDR paragraph 2
9. Registration of the set in the UDI database

Cases in which a set would have to be considered as a stand-alone device and a complete conformity assessment procedure must be completed:

•        Combination of devices without CE marking
•        Use of devices outside their original intended purpose

We will be happy to assist you with any questions you may have about placing systems and treatment centers on the market. Contact us directly!

(No ratings yet)

Loading...