In May 2020, the new EU Medical Devices Regulation (MDR) was fully enforced, then applying to 500,000 medical devices sold in Europe and the European Union (European Union Area). Shortly after the updated MDR came the In Vitro Devices Regulation (IVDR), replacing the IVDD directives in May 2022. An essential propellant for implementing updated regulations for the sale of medical devices in Europe was to place a stronger emphasis on monitoring devices from launch through the device’s entire lifecycle. These very changes call for additional regulatory documents and in vitro translation. New Challenges After the initial period of 5 years, the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices will fully replace Directive 98/79/EC on in vitro diagnostic medical devices. The IVDR aims to establish a well-regulated, smoothly functioning market for in vitro diagnostic medical devices within the EU better aligned with international guidelines. The new IVDR (and MDR) come with additional challenges for medical device manufacturers, importers and distributors. Regulatory documents will require frequent updates, stringent reporting, and more documentation that must be written and translated to some or all 24 official EU languages, depending on where the devices are sold. Key Differences The IVDR is approximately four times longer than the previous regulation IVDD. There are several points that every in vitro device manufacturer should be made aware of: 1. There are no “grandfathering” clauses in the IVDR. 2. Over 90% of devices will need conformity assessment with a Notified Body. Only Class A devices will be able to self-certify. 3. Provisions for software are included in the regulations of IVDR. As part of an IVD, software as a medical device (MD) and apps are regulated under IVDR. 4. There are more post-market surveillance requirements in IVDR, and they are more rigorous than those in the IVDD. 5. A more detailed description of essential requirements and an increased role for standard technical specifications. 6. There is a new rule-based risk classification system for IVDs with four classes. 7. Enhanced transparency and traceability through the EUDAMED database for medical devices and a unique device identifier (UDI) 8. Translation is paramount to ensuring patient safety, which is central to the new regulations. Moreover, it is essential to provide accurate translation and culturally relevant localization to ensure that in vitro devices can obtain the coveted CE mark and maintain it. Patient-centric, safety-focused regulations aim to be the gold standard worldwide. Having proactively recruited additional subject matter experts, Morningside is fully prepared to guide you through the translation and localization requirements and help you succeed in the new IVDR landscape. IVDR Roll-Out To address challenges in IVDR implementation, including the limited number of NBs, the European Commission proposed a progressive roll-out of the IVDR. Regulation 2022/112, which entered into force on 28 January 2022, amends the transition periods as follows: Original certificates for IVDs issued by a notified body under the IVDD remain valid until the end of their validity period, or at the latest, May 2025. That is provided that there are no significant changes in the design and intended purpose of the device(s). Upcoming developments Several initiatives will be associated with the implementation of IVDR: • Additional harmonized standards on in-vitro devices. • EUDAMED will be fully operational by Q2 2023 and live in Q4 2023 • Post-market surveillance requirements guidance, repackaging and relabeling and medical device nomenclature guidance. In Vitro Translation Creating high-quality marketing materials for your products takes significant time and effort. Still, your messaging and impact can get lost in translation if your content isn’t adequately localized. Morningside helps leading pharma, biotech, and device companies take their ideas and products global with a full suite of solutions for translating websites, brochures, ads, and other marketing collateral. Our highly-skilled translators are native speakers of the target language, knowledgeable in scientific and medical terminology, and have experience in marketing communications. This unique combination ensures accurate, culturally adapted translations that resonate with your target audience. Succeeding in the global marketplace requires translations that accurately and skillfully communicate your key message and brand to your target audience. It’s not enough to translate the text—the content must also be localized to reflect your audience’s culture and stylistic preferences. Whether you need to localize a product website into Brazilian, or Portuguese, or translate a sales deck for the Japanese market, Morningside’s marketing services include translators who bring the knowledge and experience to prepare effective and culturally sensitive marketing materials in 200+ languages. Global 500 companies, research institutions, and CROs rely on Morningside’s trusted marketing translations services for language support for every phase of the product lifecycle—from patent to post-market. Our expertise covers the spectrum of therapeutic and technical proficiencies. Our linguists are rigorously vetted to ensure end-user comprehension and preservation of intended meanings, whatever the subject matter. Thriving in the new IVDR landscape: In Vitro Translation Morningside offers comprehensive regulatory translation solutions to help simplify global compliance and ensure accurate, on-time submissions. Clients rely on our regulatory expertise to deliver precise linguistic translations and comply with all local and cultural requirements. We have over 20 years of experience helping global drug & device companies overcome regulatory hurdles, preparing their documentation for governing bodies worldwide, including the FDA, EMA, CFDA, SFDA, and PMDA. Contact us to get started!