{"id":103594,"date":"2024-11-04T08:10:03","date_gmt":"2024-11-04T07:10:03","guid":{"rendered":"https:\/\/lightweb.dev\/s\/key2compliance\/?p=103594"},"modified":"2025-04-11T15:32:40","modified_gmt":"2025-04-11T13:32:40","slug":"research-use-only-ruo-vs-device-for-performance-study","status":"publish","type":"post","link":"https:\/\/lightweb.dev\/s\/key2compliance\/blog\/research-use-only-ruo-vs-device-for-performance-study\/","title":{"rendered":"Research Use Only (RUO) vs. Device for Performance Study"},"content":{"rendered":"\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"Zahra\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Zahra Mavajian<\/span>
Regulatory affairs specialist – GBA Key2Compliance AB<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Disclaimer: This article is provided for informational purposes only and should not be considered official text. Always check and follow applicable local rules and regulations.<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Startups in the medical device or in vitro diagnostic (IVD) sectors often face challenges in obtaining regulatory approvals quickly, whether it be CE marking in the EU or FDA clearance or approval in the US. In some cases, companies may initially classify their products as Research Use Only (RUO) to facilitate early-stage research and development. This article provides an overview of RUO and compares it with devices for performance study.<\/p>

1. Research use only (RUO)<\/h3>

RUO products are intended solely for research and development and not for medical or clinical diagnostics. They do not fall under the definitions of Medical Devices or In-vitro Diagnostic Medical Devices (MD, IVD), and thus, the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) do not apply. RUO products are not subject to general controls such as manufacturer registration, product listing, GMP compliance, or adverse reaction reporting (Ref2).<\/p>

It is crucial to label RUO products clearly, for example, \u201cFor Research Use Only – Not for use in diagnostic procedures.\u201d The 2004 MEDDEV guidance (Ref1) emphasizes that RUO products must have no intended medical purpose. This guidance is still relevant and provides detailed information on categorizing RUO products.<\/span><\/p>

RUO products are not the same as general laboratory use products. The current regulations for in vitro diagnostic medical devices (IVDR) (Ref3) do not apply to products for general laboratory use or research use only products unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro medical device examination, according to IVDR article 1 point 3.a.<\/span><\/p>

There are not many rules to regulate RUO products under current regulations, but it is emphasized that they should be clearly labeled on the packaging and in the instructions for use (IFU) that the product is intended for research. For example, labeling should state \u201cFor Research Use Only – Not for use in diagnostic procedures.\u201d<\/span><\/p>

Regulations for RUO products vary globally. The table below shows three different submission complexities for RUO products, followed by a list of countries where these apply.<\/span><\/p>

Table 1. RUO oversight comparison in key markets across the globe. (Ref 2)<\/em><\/p>

\"RUO<\/a><\/p>

2. Device for Performance Study<\/h3>

According to IVDR 2017\/746, a device for performance study is defined in article 2, point 45 as \u201ca device intended by the manufacturer to be used in a performance study. A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study.\u201d Although devices for performance study are not intended for clinical use and their performance is to be tested in a lab environment, they still need to comply with the general safety and performance requirements set out in annex 1 IVDR. As mentioned in chapter 6 article 57 IVDR, every aspect covered by the performance study should be considered with regards to precautions to protect the health and safety of the patient, user, and other persons.<\/p>

Just like RUO devices, the intention of the device must be clearly stated on the packaging and in the IFU, for example, \u201cFor performance study.\u201d In contrast with RUO products, for which not much information is provided in IVDR, there are plenty of detailed regulations specified for devices intended for performance study given in IVDR. When there are risks for the subjects of the studies, the manufacturer or sponsor must submit an application to the authorities in accordance with article 58, IVDR. A device in the performance evaluation phase could be made available to institutes or labs to run one or more evaluation studies to gather information on performance evaluation.<\/p>

But why is IVD performance evaluation so important? The answer lies in the critical role of IVD devices. For example, consider a cancer diagnostic test. What are the consequences of potential errors, such as a lab test incorrectly showing a negative result and missing a patient (false negative)? This can have severe health consequences for the patient, who will not be diagnosed in time and may receive treatment too late. Additionally, there are significant consequences for the manufacturer, who might lose market share due to a bad reputation and have to deal with complaints about the adverse effects.<\/p>

For market investigation or even a feasibility study, one can determine the suitability of the product before CE marking for its intended use by using it as a device for performance study. The difference is that during a market investigation, the product undergoes a performance evaluation instead of being used for basic research, and therefore these studies should be covered by regulations for in vitro diagnostic medical devices.<\/p>

3. \u00a0Professional Guidance<\/h3>

Regardless of your product development phase, it is wise to seek professional guidance to ensure compliance and secure a market position. Think wisely, assess your resources, and reserve a good market place for your device in advance by letting professionals guide you through the right path to compliance and market entry.<\/p>

We can help you to ensure compliance!<\/p>

References<\/h5>

1. Guidelines on Medical Devices, IVD guidance: Research Use Only products, a guide for manufacturers and notified bodies. DocsRoom – European Commission (europa.eu)
MEDDEV. 2.14\/2 rev.1
2.\u00a0Risk-based Regulatory Oversight of Research Use Only (RUO) Products.\u00a0APAC MED, 2021
3. Regulations (EU) of the European parliament and of the council of 5 April 2017 on in vitro diagnostic medical devices.\u00a0IVDR 2017\/746<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Zahra MavajianRegulatory affairs specialist – GBA Key2Compliance AB Disclaimer: This article is provided for informational purposes only and should not be considered official text. Always check and follow applicable local rules and regulations. Startups in the medical device or in vitro diagnostic (IVD) sectors often face challenges in obtaining regulatory approvals quickly, whether it be […]<\/p>\n","protected":false},"author":3,"featured_media":116135,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"wds_primary_category":192,"footnotes":""},"categories":[192,21],"tags":[],"blog-subject":[],"class_list":["post-103594","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts\/103594","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/comments?post=103594"}],"version-history":[{"count":3,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts\/103594\/revisions"}],"predecessor-version":[{"id":126068,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts\/103594\/revisions\/126068"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media\/116135"}],"wp:attachment":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media?parent=103594"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/categories?post=103594"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/tags?post=103594"},{"taxonomy":"blog-subject","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/blog-subject?post=103594"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}