Managing IVDR regulatory uncertainty for localization

blood samples in test tubes

Rebecca Ray is a senior analyst at the independent market research firm CSA Research. Ray’s primary research focus at CSA Research is enterprise globalization, multilingual SEO and global product development.

Rebecca Ray headshot

Rebecca Ray

Rebecca Ray headshot

Rebecca Ray

Rebecca Ray is a senior analyst at the independent market research firm CSA Research. Ray’s primary research focus at CSA Research is enterprise globalization, multilingual SEO and global product development.


he European Union’s new In Vitro Diagnostic Regulation (IVDR) for medical devices goes into effect on May 26, 2022. Compliance, product marketing and localization teams at medical device firms are already seeking guidance for how best to equip themselves for local language support under the new regulatory framework. Many guidelines are still up in the air with no authoritative body to consult for concrete input on global content strategies. So without trying to answer every question about multilingual compliance under IVDR, here is a snapshot of current challenges and possible actions to take to better prepare for the new landscape.

Proactivity replaces reactivity

With so much technological change driven by underlying jumps in knowledge being applied to the healthcare field, it was only a matter of time before regulatory oversight would be pressured to catch up. In addition, European regulators were forced to update two directives — the Medical Device Directive (MDD) and the In Vitro Diagnostic Directive (IVDD) — after a series of health-related scandals. The most public of these was imploding silicone breast implants sold by a French company. As a result, the Medical Device Regulation (MDR) is slated to go into effect in May 2021, followed by the IVDR in May 2022. The former covers medical devices in general, while the latter will regulate in vitro diagnostic (IVD) medical devices that are used to perform diagnostic tests and screenings, such as HIV blood tests, pregnancy tests and blood sugar monitoring. IVDR sets up four risk classes: A, B, C and D, with D being the highest risk. It covers 27 countries and 24 languages.

ivdr classification low and high risk graph

Localization requirements and challenges

Most firms are still in the exploratory or preparation phase at the product and compliance levels vis-à-vis IVDR. Why? Many of these same companies are still focused on what needs to be done to comply with the new MDR, which goes into effect in May 2021. Various EU-level bodies are still issuing clarifications for the regulation itself. Very few Notified Bodies (NBs) — the gatekeepers for product approval in the European market — have been designated so far, with many previous ones pulling out all together. But one thing remains the same: any delay in releasing a device at any stage of the process due to language-related issues can quickly translate into millions, or even billions, in lost revenue and market share.

Manufacturers and their supply chain must prepare for a content tsunami. No matter what the final guidances and follow-on laws turn out to be, the IVDR means vastly increased content volumes — and thus more translation — much earlier than under IVD and ongoing throughout the life of a product. Member states will no longer be allowed to choose their language set; instead, all packaging and labeling must be in the national language and “clearly comprehensible to the intended user or patient.” The only way to meet the tight turnaround times for such large volumes under IVDR will be to work with content creators and the language supply chain to apply intelligent content analysis throughout the process.

chart of countries and languages that must comply with ivdr

Thus, more than ever before, manufacturers must learn to manage multiple data formats no matter where they originate or where they go afterwards. Optimizing the translation process downstream for optimal reuse won’t be enough — localization teams must collaborate with creators, packaging, labeling and compliance colleagues to ensure that the entire content pipeline is made agile, and that people and processes are upgraded to meet the rigorous quality constraints and strict timeframes. If machine translation is still categorized as a “to do,” it’s time to figure out how to implement it.

Translation requirements remain unclear. Language teams at most manufacturers are wondering if they should start localizing now without a clear picture of exactly what will be required, or if they should wait until Notified Bodies are designated and the relevant guidelines go into effect. Translation requirements are only referenced about 60 times across the whole regulation text. It’s up to the Competent Authorities in each member state to mandate the language support for manufacturers. These same groups will also determine at some point which device information — instructions for use (IFUs), labels and documentation demonstrating conformity — must be localized.

The challenge is that no one is quite sure which languages will be required for all of this. For example, do all post-market studies in Slovakia need to be translated into all 24 languages? Preemptive localization may be one route to take. Some companies — especially ones with large product portfolios — are betting on preemptive localization for certain components. It’s a risk without NB guidance, but it may also turn out to be a potential win. Even if they discover later on that they’ve made the wrong choices in some cases, the process to recover lost ground will be more of a retooling, rather than scrambling to get everything done at the last minute.

Unique device identifiers (UDIs) will impact packaging. Most devices will be required to have a UDI on their label and packaging, and for certain devices, on the product itself. This is a major new requirement under IVDR. Even though the approach will resemble what is applied in the United States, manufacturers with systems in place will still need to modify some of their rules. They will also need to set up a standard process and implement technology to handle regional and risk classification variations.

Be prepared to participate in label redesign at your company to integrate the UDI, along with the resulting text expansion or shrinkage required during the localization step. It won’t be easy with the overflow of information destined for a very small amount of space.

European Database on Medical Devices (EUDAMED) will rule pre- and post-market. All documents and data are to be in multiple languages corresponding to the countries in which devices are sold. One prime example of this under the new regulation will be the requirement for NBs to upload the Clinical Evaluation Consultation Procedure (CECP) to EUDAMED. At that point, manufacturers are obligated to translate this content within a month’s time to all languages for the markets they support and send them to the NB to be uploaded.

Collaborate with your NB and language supply chain to ensure that all systems and processes can ramp up to complete translations under much faster turnaround times. Ensure that all participants involved in uploading to EUDAMED are properly trained. Timelines should be made clear as far in advance as possible and should account for holidays and other predictable bottlenecks.

Factor Brexit into your planning. If you plan on doing business as a non-UK firm in the UK, you will need to work with an NB qualified to run conformity assessments there. However, non-EU manufacturers that have leveraged the UK as their base for the EU can no longer use this model. And if you’re a UK firm continuing to export beyond your border and plan to depend on an NB headquartered in the UK, make sure they have been/will be designated to move with you. As of January 2020, BSI Group is the only NB in the UK certified for EU-27 markets. It’s possible that the UK will implement the same regulatory structure as the IVDR, but no one knows for sure at this point.

Your company is probably already making contingency plans for the fallout from Brexit, so your job is to make sure that whoever is responsible has timely input related to any multilingual requirements that may be changing as a result. And if your global content production process is not already based on DITA or some structured and automated way to implement changes across multiple documents simultaneously, you will have to make time to implement basic edits, such as address changes and other alterations as required by your NB.

As your company ramps up to comply with the new IVDR, the overarching challenge is to manage regulatory uncertainty. Each corporate culture will approach and deal with it differently. Your goal is to ensure that colleagues and executives do not duck multilingual deliverable issues as they freak out about the ambiguity within the new framework. Don’t take “no” for an answer when it comes to participating upfront in areas such as Notified Body selection, technology upgrades and decision-making around legacy products.