--- title: 5 Tips to Get Ready for the New EU In-Vitro Diagnostic Device Regulation description: A five step overview on how to implement the new EU in-vitro diagnostics device regulations for your lab automation products. image: https://blog.hseag.com/hubfs/EU%20IVD%20regulations-1.png --- hide-section - [Blog](https://blog.hseag.com/) - [Careers](https://www.hseag.com/hombrechtikon-systems-engineering-careers/) [** ](https://www.facebook.com/HSEAGWhereScienceAndTechnologyEvolve) [** ](https://www.linkedin.com/company/17940231/) [** ](https://www.xing.com/xbp/pages/hse-ag) [EN](https://blog.hseag.com/old/eu-in-vitro-diagnostic-device-regulations#) [**](https://blog.hseag.com/old/eu-in-vitro-diagnostic-device-regulations#) ** ** [![hseag-logo-2x.png](https://blog.hseag.com/hs-fs/hubfs/HSE%20AG%20August%202017/hseag-logo-2x.png?width=272&name=hseag-logo-2x.png "hseag-logo-2x.png")](https://www.hseag.com/) ![hseag-logo-2x.png](https://blog.hseag.com/hs-fs/hubfs/Logos/hseag-logo-2x.png?width=272&name=hseag-logo-2x.png "hseag-logo-2x.png") [< Prev ](https://blog.hseag.com/old/bike-to-work-2019) [Well-being Through Bike to Work — 2019 Results Are In!](https://blog.hseag.com/old/bike-to-work-2019) 19 July, 2019 [**](https://blog.hseag.com/) [Next > ](https://blog.hseag.com/old/miptech-2019) [HSE•AG will be at MipTech Basel, 9-12 September 2019!](https://blog.hseag.com/old/miptech-2019) 19 July, 2019 [Technology Hub](https://blog.hseag.com/old/tag/technology-hub) # 5 Tips to Get Ready for the New EU In-Vitro Diagnostic Device Regulation Jul 19, 2019 9:03:41 AM ![EU IVD regulations-1](https://blog.hseag.com/hubfs/EU%20IVD%20regulations-1.png) By end of 1998, the first European quality and safety requirements for in vitro diagnostic medical devices, the ***European Directive 98/79/EC (IVDD),*** stepped into effect. After almost 20 years in May 2017 the new ***European ******Regulation (EU) 2017/746***  ***(IVDR)*** was published to repeal the IVDD, and set a universal quality standard to better accommodate emerging medical technologies.    However, the to-do list to ensure that new and already registered IVD products comply with the regulations seems long and complicated for many in vitro diagnostic device manufacturers. Further, the implementation schedule is non-compromising. But not to worry. We’ve gathered together a step-by-step guide for you to implement the new EU regulations in an organized, rudimentary and risk-free pivot. # 1. Know the transition schedule The strict implementation schedule puts pressure on Notified Bodies, authorities and manufacturers. As falling behind deadlines poses the risk to lose company authority and business, keeping track of when changes need to be achieved is critical. It's also essential to know until when and under which conditions the IVD products can be placed and /or made available on the market. The most important dates in the IVD regulation transition period for products that are not subject to certification by a Notified Body are shown below:   ![EU IVDR timeline HSE AG](https://blog.hseag.com/hs-fs/hubfs/EU%20IVDR%20timeline%20HSE%20AG.png?width=1185&name=EU%20IVDR%20timeline%20HSE%20AG.png) * T**imelines for IVDD and IVDR medical devices *   Based on the associated or assumed risk class of your products and the status of the related R&D -projects, your regulatory road-map should be defined to determine which approach fits best with your marketing plans and the existing and new requirements of the applicable directive (IVDD) or regulation (IVDR).   # 2. Define your scope and context An important part of the regulatory strategy is to consider and understand the scope of activities that apply only to your operations. Consider the following topics:   1. a) What* is the defined or planned intended use of your device?* 2. *b) Is your company located inside or outside of the EU?* 3. *c) Do you need a Notified Body to assess the conformity of your device?* 4. *d) What are your sales and distribution channels?* 5.   Answering these metrics will ensure that you focus on the appropriate regulatory changes for your organization.    # 3. Check your Indented Use -statement carefully The effort required for the upcoming processes and documentation depend on the risk class and intended use of your device. The IVD device -based on the associated risk categorizes products into List A, List B and “other devices”, whereas the IVD regulations define four risk classes from A (low-risk) to D (high risk). The same intended use of a device may therefore lead to different classifications under IVDD or IVDR. As a result, devices that are marketed based on the manufacturers self-declaration might require a Notified Body for conformity assessment, adding time, cost and effort to your projects.    # 4. Update your internal quality management system The new EU IVD regulation enhances manufacturer's quality management system (QMS) requirements to cover all relevant aspects to quality of processes, procedures and devices. Depending on the risk class of the device, the QMS may be subject to regular, unannounced or for-cause audits by a Notified Body, and the more prepared you are for a surprise audit, the better. Under the new regulation, manufacturers are required to assign a person to be responsible for regulatory compliance, with the requisite expertise in the field of in vitro diagnostic medical devices and fulfilling minimum conditions of qualification. * * # 5. Avoid unnecessary bureaucracy Given that regulatory requirements have increased by the new regulation, to choose the most efficient and effective way to address and implement these is a key factor for your company’s success. A good start is to carefully analyze your current set-up, projects and plans, and then move on to develop a stringent regulatory road-map. If you focus on required compliance and apply the least burdensome implementation approach, you'll be on a secure path towards a rapid turnover of your devices for the European market.   If you are interested in a detailed EU IVDR implementation checklist, click download below:   **[![Download IVDR Checklist](https://hubspot-no-cache-eu1-prod.s3.amazonaws.com/cta/default/3399857/b01a7481-e3dd-4bbe-ae8f-ccef720270b7.png)](https://hubspot-cta-redirect-eu1-prod.s3.amazonaws.com/cta/redirect/3399857/b01a7481-e3dd-4bbe-ae8f-ccef720270b7)**   **This post does not substitute for following the [official guidelines](https://ec.europa.eu/growth/sectors/medical-devices_en) provided by the European Union. ** We have more tips for you! Check out our FDA Regulations post [here](https://blog.hseag.com/fda-registration-of-ivd-laboratoty-instruments-in-the-us-market). Posted by Pit Muggli ** ### RECENT POSTS [Processes, the driving force in projects](https://blog.hseag.com/old/making-processes-the-driving-force) Jun 30, 2022 8:15:00 AM [The Engineering Key to Economic Syndromic Testing Success](https://blog.hseag.com/old/the-engineering-key-to-economic-syndromic-testing-success) Nov 24, 2021 3:07:29 PM [Meet Us at DxPx conference in Düsseldorf](https://blog.hseag.com/old/dxpx-conference-2021) Oct 29, 2021 1:55:47 PM [Video: Speed up Robotics in Conjunction with Smart AI – Enabling Improved Business Cases](https://blog.hseag.com/old/webinar-robotics-smart-ai) Jun 30, 2021 10:47:07 AM [Meet Us at FUTURE LABS LIVE 2021 and Attend Our Smart AI Webinar!](https://blog.hseag.com/old/future-labs-live-2021) Jun 1, 2021 1:59:23 PM [❄️ Season's Greetings ☃️](https://blog.hseag.com/old/seasons-greetings-2020) Dec 16, 2020 2:05:53 PM [HSE•AG closing another succesful year - Annual Report 2019](https://blog.hseag.com/old/annual-report-2019) Aug 20, 2020 10:59:38 AM [Video: Microfluidics Is Not The Challenge – Everything Around It Is!](https://blog.hseag.com/old/webinar-microfluidics-diagnostics) Aug 18, 2020 1:05:27 PM [Farewell Mirjana — Special Agent Kozulic Is Retiring](https://blog.hseag.com/old/mirjana-kozulic-retiring) Jun 25, 2020 9:31:20 AM [Meet Us at SLAS Transformed 2020 and Attend Our Microfluidics Webinar!](https://blog.hseag.com/old/slas-transformed-2020-microfluidics-webinar) Jun 9, 2020 8:51:06 AM [![](https://blog.hseag.com/hs-fs/hubfs/hseagohnesubzeile_farb-1.png?noresize&width=150&name=hseagohnesubzeile_farb-1.png)](https://www.hseag.com) Our mission is to create the tools that unravel the secrets of life – one life science & technological breakthrough at a time. By combining our engineering and application experience we create and manage complete or partial system solutions and adapt to specific customer needs to simplify their and the end users’ workflows. #### CONTACT Headquarters Garstligweg 6 CH-8634 Hombrechtikon Switzerland Phone: [+41 55 254 04 00](tel:#41552540400) Email: [info@hseag.com](mailto:info@hseag.com) North America Boston, MA USA Phone: [+1 774 433 9569](tel:+17744339569) Email: [info@hseag.com](mailto:info@hseag.com) #### NAVIGATION [Your Challenge](https://www.hseag.com/life-science-and-diagnostic-providers-challenges/) [Your Market](https://www.hseag.com/lab-equipment-markets/) [Our Solutions](https://www.hseag.com/systems-engineering-solutions/) [Our References](https://www.hseag.com/our-references/) [About Us](https://www.hseag.com/about-hombrechtikon-systems-engineering-ag/) [Blog](https://blog.hseag.com/) [Careers](https://www.hseag.com/hombrechtikon-systems-engineering-careers/) © 2018 Hombrechtikon Systems Engineering AG - All Rights Reserved [Legal](https://www.hseag.com/hombrechtikon-systems-engineering-ag-legal) | [Imprint ](https://www.hseag.com/imprint-hombrechtikon-systems-engineering-ag/) [**](https://www.facebook.com/HSEAGWhereScienceAndTechnologyEvolve) [**](https://www.linkedin.com/company/17940231/) [** ](https://www.xing.com/xbp/pages/hse-ag) ** ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "Pit Muggli", "url" : "https://blog.hseag.com/old/author/pit-muggli" }, "dateModified" : "2021-05-26T16:05:46.605Z", "datePublished" : "2019-07-19T07:03:41.000Z", "headline" : "5 Tips to Get Ready for the New EU In-Vitro Diagnostic Device Regulation", "image" : [ "https://blog.hseag.com/hubfs/EU%20IVD%20regulations-1.png" ], "mainEntityOfPage" : { "@id" : "https://blog.hseag.com/old/eu-in-vitro-diagnostic-device-regulations", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://blog.hseag.com/hubfs/logo-hubspot-rot.png" }, "name" : "HSE AG" } } ```