Basics | EU, Regulatory Basics by Regulatory & More Jan 10, 2022 Claims under the MDR and the IVDR (Art. 7/7) Overview 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 7Claims Article 7Claims 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. Recommended Reading Mariusz Malinowski. Advertising of Medical Devices and Principles of Claim Substantiation in European Union. Am J Bi–omed Sci & Res. 2021 – 12(4). AJBSR.MS.ID.001777. DOI:10.34297/AJBSR.2021.12.001777. References Consolidated text: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EECConsolidated text: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU Share on facebook Share on twitter Share on linkedin Share on whatsapp Share on email Best Sellers Template – Product Qualification and Classification under the EU IVDR 2017/746 (v.1.0) $50.00 Add to cart Checklist – ISO 13485 2016 Internal Audit (v.1.0) $50.00 Add to cart Template – SOP Master Validation Test Plan (v.1.0) $50.00 Add to cart Template – Technical Documentation Table of Content according to the IVDR (v1.0) $50.00 Add to cart Template – SOP Technical Documentation according the IVDR (v1.0) $50.00 Add to cart Related Posts Project Management How to Create a Project Timeline in Simple Steps Read More » 17 June 2022 Visual Maker How to create a Project Timeline with VisualMaker? 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