Deadline 2020: What LSPs Need to Know About the EU’s New Medical Device Regulation

The life sciences and medical device industries are famous for their rigorous translation and linguistic validation processes —  and with good reason: The potential impact of incorrect translations around a patient’s health and well-being could be fatal.

In the European Union, standards for medical device translations are about to become even stricter.

The EU Medical Device Regulation (EU MDR), which took effect in 2017, will become mandatory in all EU member states starting May 26, 2020. (The EU In Vitro Diagnostics Regulation, or EU IVDR, a related regulation specific to diagnostic tests and screenings, will become mandatory in 2022.)

Compared to its predecessor, the Medical Devices Directive (MDD), EU MDR will apply to more devices and require more thorough labels on all products.

According to the EU, “There are over 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market. Examples of medical devices are contact lenses, x-ray machines, pacemakers, breast implants and hip replacements and sticking plasters. In vitro diagnostic medical devices, which are used to perform tests on samples, include HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics.”

Most significantly for language service providers (LSPs), EU MDR will require that medical device content be translated into the official language of each EU member state where the product will be marketed (up to 24 official languages in total for products marketed throughout the EU). All CE-marked products will need to comply with EU MDR in order to retain the CE mark and stay on the market.

Much of the content to be translated can be classified as either “instructions for use” (IFUs) or patient information (patient manuals). In addition to being translated into the appropriate languages, the content for products intended for commercial use must be written so that it can be understood by a layperson.

Some have predicted that the new translation requirements may be a boon for specialized translators. This is especially true for those working in languages with fewer speakers as many companies may be vying for the same expert linguists to handle the sizeable volume of content to be translated before the EU’s deadline. 

But not everyone is racing to have their content translated so quickly.

Waiting to See What Competitors Do

In a September 2019 KPMG report, 50% of medical device organizations surveyed stated that they would be able to implement new product labeling requirements through their current business practices. On the other hand, 22% said they were modifying or adding systems to meet the new requirements, while 20% said they were “increasing headcount” to address the issue.

According to Aneta Bajda, Global Marketing Director at Argos Multilingual, an LSP with a large client base in the medical device sector, many companies are still trying to make sense of their new obligations under EU MDR. This includes understanding the timeline for required translations. 

First, it is important to recognize that different classes of products have different deadlines. (It is worth noting that the European Medicines Agency, which is involved in the assessment of certain categories of medical devices, recently moved its seat to Amsterdam from London in the wake of the Brexit vote.)

Clients have already seen the launch date for EUDAMED, the European Commission’s database of medical device information, pushed back from 2020 to 2022; which raises questions about whether EU MDR will actually go into effect by its May 2020 deadline.

“This little change is an example of what could give our clients that kind of certainty that they don’t have to rush,” Bajda told Slator. “At the same time, a lot of them are waiting to see what competitors do and how they handle it.”

Some manufacturers may also be relying on the fact that many medical devices certified under the previous regulation, MDD, do not need to comply with EU MDR until their certification expires. Bajda explained that products grandfathered under these conditions, with certifications that extend past May 2020, can continue being sold in the EU without penalty, some up until 2024.

Many medical devices certified under the previous regulation, MDD, do not need to comply with EU MDR until their certification expires.

“A lot of companies that have products certified [that will] still be valid next year won’t look to recertify them with six months left,” Bajda said. “They’ll wait until the certification becomes void.”

Once clients do decide to work toward EU MDR compliance, Bajda said, Argos encourages them to do a gap analysis and modify risk management and quality assessment processes as needed, before any translation begins.

Two Birds, One Stone

At least one company that has pursued EU MDR compliance more proactively has found that the new requirements overlap with changes that would have been advantageous even without EU MDR.

Biosense Webster, a division of Johnson & Johnson, specializes in diagnostic and therapeutic tools for cardiac arrhythmias. Labeling Manager Doron Bodner told Slator that EU MDR has significantly changed labeling requirements, especially in terms of languages and translations — but the new regulation has not affected the company’s decision to maintain its presence throughout the EU. (Prior to the introduction of EU MDR, Biosense Webster already had its content translated into all official languages of the EU, except for Greek, which it recently added.)

“We’re focused on the patients and the doctors using our products,” said Bodner. “That is what leads us moving forward — not the technicalities of translation costs or regulations.” 

“We’re focused on the patients and the doctors using our products. That is what leads us moving forward — not the technicalities of translation costs or regulations.” — Doron Bodner, Labeling Manager, Biosense Webster

According to Bodner, Biosense Webster’s translation and linguistic validation processes, which are managed by an in-house Localization Coordinator, have not changed much in response to EU MDR. The Localization Coordinator works with several LSPs to produce translations and perform quality checks. To ensure that LSPs provide top-notch quality, Biosense Webster occasionally asks LSPs to do a “translation memory swap,” or request that vendors work on different languages.

After the initial quality checks, Biosense Webster manages its own internal, in-country review (ICR) process, sending content to company representatives (e.g., sales and marketing professionals or regulatory affiliates), who live in the countries where the translations are being tested. Bodner said that this step was recently adjusted to include reviewing local regulatory requirements for specific countries so that issues related to language or regional regulations could be addressed simultaneously.

This change, Bodner said, “may have been accelerated due to EU MDR requirements, but [was] definitely something in the works” beforehand.

Biosense Webster had been planning for EU MDR compliance since the regulation was introduced in 2017, a process that included discussions with notified bodies and the European Commission to clarify the company’s obligations.

“With proper planning, we were able to meet most of the requirements, if not all of them, already, and are working on closing the gaps before the deadline,” Bodner said.

Biosense Webster’s case shows that large medical device manufacturers are likely better prepared for the regulatory change than their smaller competitors.

As Reuters reported in June 2019, some smaller companies have considered either pulling current products off the market or declining to release new products in the EU to avoid what they see as burdensome requirements.

According to a survey by German industry association ZVEI, for example, over half of medical device manufacturers are planning cuts of up to 10% of their product portfolio in view of tighter regulations.

While a stricter regulatory framework is a burden to manufacturers, it is a boon to the language industry, where the new rules will create additional opportunities for specialized providers.

Image Source: Elżbieta Bieńkowska, Member of the EC in charge of Internal Market, Industry, Entrepreneurship and SMEs