How does a professional user benefit from ensuring conformity?

The safe use of a medical device requires that several obligations are fulfilled. The purpose of the obligations of a professional user is to proactively ensure the safe use of medical devices. By complying with these obligations in professional use, it is possible to avoid situations where, for example, activities would be interrupted because the medical device is unsuitable for the intended purpose.

In its supervision, the Finnish Medicines Agency Fimea has observed that healthcare units have inadequately identified what is meant by the conformity of a medical device and how conformity could be ensured. In this news article, Fimea aims to clarify what the obligation of a professional user to ensure conformity, referred to in the national Medical Devices Act (719/2021), means. 

What does conformity mean?

A medical device is safe for the customer, the user and the environment in which it is used when it conforms with the requirements and the device is used in accordance with the instructions for use given and for the intended purpose specified by the manufacturer. Conformity means that the safety and performance of the device have been demonstrated, taking into account the medical use of the device. The device manufacturer is responsible for demonstrating safety and performance. The device manufacturer has assessed how the medical device functions safely for both the patient and the user. It is also the device manufacturer’ responsibility to indicate the intended purpose of the device.

The information provided with the device must indicate that the device is a medical device. The medical device manufacturer uses the information about the CE marked device to draw up a Declaration of Conformity. For custom-made medical devices and those manufactured by healthcare units themselves, the manufacturer provides a declaration of fulfilling the safety and performance requirements. The information provided with the declarations can be requested, for example, as part of the preparations for the procurement of a medical device.

Requirements for device manufacturers for ensuring the safety of the device are laid down in the Medical Devices Regulation (MD 2017/745) and the Regulation on in vitro diagnostic medical devices (IVD 2027/746). For example, the manufacturer must provide sufficient labelling and instructions for use together with the device. 

It is possible to ensure conformity before the device has been put into service

A professional user must take into account the intended purpose, the requirements of the environment in which the device is used, the requirements of the patient group as well as any other conditions of use and ensure they correspond to the device manufacturer’s specifications for the device. Before a medical device is put into service, it is essential to determine whether the intended need corresponds to the intended purpose stated by the manufacturer.

The intended purpose is stated in the manufacturer’s instructions for use, on the labelling of the device, and in the promotional and sales materials. The instructions for use describe information on the safe use of the device, such as warnings, contraindications and the target patient group.

In its supervision, Fimea has from time to time observed that paying attention to the information provided by the manufacturer has been overlooked in professional use, and established practices in activities guide the use of medical devices. A professional user plays a crucial role in making the safe use of a medical device possible. Fimea provides more guidance on the content of the obligations for professional use and compliance with them on its website.

Read more:

Obligations of a professional user, infographic (link in Finnish)

General requirements for professional users (link in Finnish)

How to identify a medical device?