by Regulatory & More Jan 10, 2022

Claims under the MDR and the IVDR (Art. 7/7)

Purpose (+) Scope

Marketing and advertising requirements for medical devices and IVDs are covered in the article 7 of the EU MDR 2017/745 and EU IVDR 2017/746. These requirements target any documentation, practice and statements such as product labeling, instructions for use, and product advertising.

Claims Requirements

MDR requirements and IVDR requirements are strictly similar. No differences between their articles 7 are noted.

The requirements prohibit the use of text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient regarding the device’s intended purpose, safety and performance by:

- Ascribing functions and properties to the device which the device does not have;
  - e.g. Advertising that a device intended to be used for pulmonary cancer detection only can be also be used for stomach cancer detection.

- Creating a false impression regarding treatment or diagnosis, functions or properties which the device e does not have;
  - e.g. Claiming that a device has a accuracy of 99% accuracy without having clinical evidence.

- Failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
  - e.g. Failing to inform that a device can cause an electrical shock in some circumstances.

- Suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
  - e.g. Suggesting that a device intended to be used by professional only can be also used by laid person.

Comparison Table

Differences are in orange

EU MDR – Regulation (EU) 2017/745

EU IVDR – Regulation (EU) 2017/746

Article 7

Claims

Article 7

Claims

In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by:

(a) ascribing functions and properties to the device which the device does not have;

(b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;

(c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;

(d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by:

(a) ascribing functions and properties to the device which the device does not have;

(b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;

(c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;

(d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.