The passing of Brexit in early 2020. The ongoing monitoring of candidate countries. COVID-19. Three formidable challenges have all complicated the race to EU/MDR compliance — as if the regulations weren’t already complicated enough.
Ever since the onset of the pandemic, manufacturers worldwide have seen a spike in demand for personal protective equipment (PPE) such as medical-grade masks, gloves, and ventilators, placing the medical device industry under intense pressure. Up until that point, manufacturers (and NBs) had been working around the clock to ensure their devices met MDR requirements by the May 2020 deadline. So, to many, the announcement of a one-year delay in meeting these requirements might have seemed like a welcomed relief, freeing up manufacturers’ time to focus on battling the pandemic. But the truth is, it has only complicated matters.
Along with the one-year delay has come a barrage of new guidance documents. This influx in documentation has proven quite difficult for many manufacturers — especially smaller outfits — to navigate. An increase in remote working arrangements has also meant less resources devoted to MDR compliance processes, less available time, and less NB availability for onsite inspection (a resource that was already limited to begin with). And now, here we are once again. The year delay is almost up. With May 21st, 2021 quickly approaching, manufacturers with medical devices found to be MDR non-compliant will once again risk losing their ability to sell their products in the EU marketplace — the second largest medical device marketplace after the United States.
Are you ready?
European Medical Technology Market
Valued at €120 billion (USD145 billion), the European medical technology market remains the second largest in the world. In fact, Europe constitutes roughly 27% of the global medical device market with Germany, France, the United Kingdom (UK)*, Italy, and Spain holding the largest market share.
Data Source: MedTech Europe
* The United Kingdom formally left the EU effective January 2020. Although there was some talk on whether or not the UK medical device market would adopt EU/MDR, it seems now, that they will not. Read here to learn more.
And although the United States continues to be one of Europe’s largest trading partners within the medical device industry, American manufacturers must meet heightened guidelines to successfully bring their products to the EU marketplace.
The Seismic Shift to EU/MDR
In the past, it was relatively easy for most US-based medical device manufacturers to sell their products in Europe. After all, manufacturers simply had to show that the devices performed as intended and were likely to be safe. But this rather lackadaisical approach led to a growing number of recalls and safety issues. Clearly, it was time for a shift in regulations — what the industry hadn’t quite realized, however, was how seismic that shift would become.
Whether launching a novel device or wishing to bring a legacy product to the European market, manufacturers must now ensure compliance on a great many levels. Aside from greater emphasis on performance evaluation, an increased emphasis on clinical data, increased technical documentation requirements, increased post-market requirements, and increased transparency, manufacturers must also comply with new, stringent language requirements.
EU/MDR Language Requirements
Gone are the days when manufacturers could simply overlook translation as an integral part of ensuring user safety and appropriate product use. In fact, under the new EU/MDR, a decision to treat language requirements as an afterthought could prove costly. Those wishing to comply with the new regulations must now pay close attention to the official languages of each EU Member State in which they wish to sell their devices. Under the new regulations, all translations must be precise, clear, and easily understood by the end user. In addition to labelling and IFUs, translations will now also be required for marketing collateral, clinical performance documentation, operating manuals, patient manuals, and more.
So, just how many official languages are there and what are the official languages recognized by the EU? We’re glad you asked.
Official EU Languages
The EU currently recognizes 24 official languages. And although English is still unquestionably the most spoken language in the EU, this is not the case when it comes to native speakers. In fact, German, French, and Italian rank as the three most widely spoken languages of native speakers throughout Europe.
Data Source: Wikipedia
In addition to these 24 official EU languages, however, you might also wish to consider four more if you plan to distribute your devices to the EEFTA/EEA states, as well as to Switzerland and Turkey.
EEFTA/EEA Agreements
With the establishment of the European Economic Area (EEA) in 1994, the EU Single Market for medical devices also extends to members of the European Free Trade Area (EFTA), namely Norway, Liechtenstein, and Iceland.* Should manufacturers wish to sell their products to members of the EFTA, required documentation will need to be translated into Icelandic and Norwegian, the respective official languages of Iceland and Norway.**
* Although Switzerland is part of the EFTA, the country does not participate in the EEA.
**The official language of Liechtenstein is German.
Switzerland and Turkey
Currently, Switzerland does not wish to participate in the EEA but the country still requires all medical devices to have CE marking. To complicate matters even further, Turkey, too, requires CE marking although it is neither a member of the EU nor part of the EEA. This essentially means that Romansh and Turkish can conceivably be added to the total list of languages to consider for MDR translation.
Increased Distribution Opportunities
For some manufacturers, these additional language requirements might initially seem overwhelming but what they truly represent are opportunities for growth. After all, manufacturers wishing to enter the EU Single Market now have access to over three dozen countries. Should manufacturers choose to invest in professional translation services, they will only increase the likelihood of competing successfully in as many as 28 languages.
Ingenuiti — Your Trusted Language Services Partner
Ensuring compliance under the new MDR can seem more than a little daunting. With a significant increase in the volume of documentation that must meet full MDR compliance, manufacturers are feverishly looking for an experienced language services provider (LSP) they can trust. Welcome to Ingenuiti.
Our professional team of linguists will accurately translate all required documentation in as many languages as you require. From technical documentation and patient manuals to labeling, IFUs, and marketing collateral, we have you covered. By partnering with Ingenuiti, you will also enjoy the added comfort knowing that you are working with an ISO 13485:2016 certified LSP. And since the new MDR regulations lean heavily on this certification, you can rest assured that you are in the best of hands. Simply put, our quality management processes are second to none. Don’t let another day pass you by. Partner with Ingenuiti, and together, we’ll help ensure you are MDR compliant and meet the quickly approaching deadline.
REFERENCES
“EU MDR Panel Discussion: Why An Extra Year Is Not Really A Delay For The MDR – How To Survive Changing And Confusing Times.” Medtech Insight, medtech.pharmaintelligence.informa.com/MT142211/EU-MDR-Panel-Discussion-Why-An-Extra-Year-Is-Not-Really-A-Delay-For-The-MDR–How-To-Survive-Changing-And-Confusing-Times.
“Market – MedTech Europe – The European Medical Technology in Figures.” MedTech Europe, 14 Jan. 2021, www.medtecheurope.org/datahub/market/.
“UK List of Designated Standards for Medical Devices Published.” Bsi, Bsi, 2 Feb. 2021, compliancenavigator.bsigroup.com/en/medicaldeviceblog/UK-designated-standards/.
Hwang, Thomas J, et al. “Comparison of Rates of Safety Issues and Reporting of Trial Outcomes for Medical Devices Approved in the European Union and United States: Cohort Study.” The BMJ, British Medical Journal Publishing Group, 28 June 2016, www.bmj.com/content/353/bmj.i3323.
Keating, Dave. “Despite Brexit, English Remains The EU’s Most Spoken Language By Far.” Forbes, Forbes Magazine, 7 Feb. 2020, www.forbes.com/sites/davekeating/2020/02/06/despite-brexit-english-remains-the-eus-most-spoken-language-by-far/?sh=7c6d0c4d412f.
“Languages of Europe.” Wikipedia, Wikimedia Foundation, 24 Feb. 2021, en.wikipedia.org/wiki/Languages_of_Europe.
“The European Economic Area (EEA), Switzerland and the North: Fact Sheets on the European Union: European Parliament.” Fact Sheets on the European Union | European Parliament, www.europarl.europa.eu/factsheets/en/sheet/169/the-european-economic-area-eea-switzerland-and-the-north.
Burton, Patrick. “Marketing, Manufacturing, Packaging & Labelling, Advertising: Turkey.” PharmaBoardroom, pharmaboardroom.com/legal-articles/marketing-manufacturing-packaging-labelling-advertising-turkey/
