According to data from the European Union, there are over 500,000 different medical devices on the EU market. This could include anything from contact lenses to a hip replacement, or even bandages. Translation for the medical device sector has a reputation for being detail-oriented and precise, which is only logical as an inaccurately translated instruction manual could have serious implications for the person using the device. This is one of the reasons that the European Union introduced stricter regulations for medical devices with the European Medical Device Regulation (EU MDR). In this article, we’ll be looking at what EU MDR means for medical device companies and how it relates to translation.
What is EU MDR?
EU MDR took effect in 2017 and was originally intended to be mandatory for all European member countries on May 26, 2020. It has since been postponed for one year in the context of the coronavirus pandemic, thereby moving the application date to May 26, 2021.
EU MDR encourages a ‘lifecycle approach’ to regulation, making medical device companies responsible for their products throughout the entire product lifecycle. It increases labelling requirements and also requires that labels are translated into the language of the country where the product will be marketed. These new regulations are intended to protect the European population via more transparent medical device technical information. They also reflect the growth in Software as a Medical Device (SaMD) as it was less prevalent when EU MDR’s predecessor, MDD, was introduced in 1992.
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What is the difference between EU MDR and MDD?
Even if your company was MDD compliant, it’s important to keep in mind that this does not mean you are automatically EU MDR compliant. MDD was essentially a checklist for medical device companies to receive their CE marking. EU MDR differs from MDD in that it is a regulation rather than a directive, meaning that it is applied as domestic law in all EU countries. EU MDR is also significantly more detailed than the MDD, with 174 pages in comparison to the MDD’s 60 pages.
From a translation perspective, the EU’s EU MDR FAQ website explains that the MDD’s passive Article 4 (4) which states that “Member States may require… the information accompanying the device in national language(s)”, has been replaced by the EU MDR’s active Article 10 (11) which says “Manufacturers shall ensure… the information accompanying the device is in national language(s).” Translating documentation into national languages is now an requirement rather than an option.
You can find a complete list of the new requirements on the EU’s website.
What does this mean for medical device companies operating in the EU?
Under EU MDR, existing products need to be recertified. The three-year transition period was intended to give companies time to adapt and comply with the new regulations, which mean that manufacturers will need to include more information in their products’ technical documents.
It is also important to note that all products with a CE marking will need to comply with EU MDR in order to stay on the market. Beginning in 2025, it will be impossible to sell or distribute products without EU MDR certification.
Translation and EU MDR
Translations are a critical aspect of EU MDR. The regulations require that all content and documentation, including Instructions for Use (IFUs) and patient guides, are translated into the official language of the member country where the device will be marketed. Therefore, medical device documentation will need to be translated into all 24 EU languages. This is a change for companies who previously only translated their content into a few languages of their choice. In addition, the regulations stipulate that medical device content must be written so that it can be easily understood by a layperson. Therefore, it is important to work with expert translators who have experience translating documents for use by the general public.
At Acolad, our team of Life Sciences translation specialists are ready to assist you with the translation of your medical device documentation. Our project managers and linguists have years of experience in the medical sector and have undergone extensive training. We comply with EMA standards and are ISO 9001:2015, ISO 17100 and ISO 13485-certified, so you can be confident that you’ll receive high-quality, precise translations every time.
Do you need to translate documents for EU MDR? We can help.