Do all medical devices have to be certified?

Do all medical devices have to be certified? The subject of certification of medical devices regularly appears in the inquiries of our clients. To answer the question posed in the title, reference should be made to both national and EU legal regulations. The Act on Medical Devices of May 20, 2010 (as amended) clearly states which products must undergo mandatory conformity assessment by the manufacturer or his authorized representative under the supervision of a notified body, i.e. a certification body. This assessment ends with the issuance of a certificate confirming the fulfillment of the essential requirements by a given medical device. This procedure concerns, in accordance with the provisions of Art. 29 section 5 of the Act, the following classes of medical devices:

1) class I medical devices with a measuring function,
2) class I sterile medical devices,
3) class IIa medical devices,
4) class IIb medical devices,
5) class III medical devices,
6) active implantable medical devices,
7) in vitro diagnostic medical devices from list A,
8) in vitro diagnostic medical devices from list B,
9) devices for self-control

In other words, class I medical devices are subject to self-assessment of conformity without the participation of a notified body, therefore, in the case of this class of products, we are not talking about certifying them, but only issuing a declaration of conformity by the manufacturer.

Do all medical devices have to be certified?

So what are class I medical devices and do all medical devices have to be certified?

The manufacturer of the medical device decides about its qualification. The higher the product class, the more restrictive the conformity assessment procedure. In the case of class I medical devices, we are dealing with devices with relatively the lowest risk of use. According to the regulation of the Minister of Health of 5 November 2010 on the classification of medical devices, class I devices in rule 1 are non-invasive devices that are not subject to any of the other rules – there are 18. For the sake of simplicity, examples of class I medical devices are e.g. . orthopedic collars, examination gloves, surgical masks, manual wheelchairs, walking frames or crutches. It is for this group of products that certification by notified bodies is not applied. Nevertheless, in the media, the term certification of medical masks is often used.

In the maze of legal regulations regarding medical devices, it is so important to have knowledge and a reliable partner. Therefore, a team of CeCert experts offers services in the field of assessment of documentation provided by manufacturers of medical devices, including class I. We invite you to cooperate with us.

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