Understanding the New EU MDR Update and Its Effect on Medical Device Translations
The European Union Medical Devices Directive (MDD) was established in 1994 to regulate medical devices sold within the EU. MDD was applicable to all medical devices sold within the European market, and it listed specific requirements meant to standardize medical device technical qualifications, basic testing procedures, and regulatory and certification guidelines. The MDD has been used as a framework by medical device manufacturers for over two decades to ensure their product complies with strict EU standards.
The MDD was established before the age of the Internet, and the modernization of technology has caused this legislation to be outdated.
As a result, the EU Medical Device Regulation (MDR) has been created to increase patient safety by placing stricter regulations on European medical devices. With the goal of improving the lifecycle of each product, while making it easier for patients to use and operate the devices, the MDR is meant to improve overall health and regulate the use of medical devices in the EU.
In early 2023, the European Council approved a measure to extend the transition period for medical devices under the MDR regulation. The updated transition deadlines are:
May 2026 for Class III custom-made implantable devices
December 2027 for Class III and IIB implantable devices,
December 2028 for Class IIB non-implantable devices, Class IIA, and Class I devices,
the sell-off requirements for all products under MDR and IVDR will no longer apply. (Updated May 2023)
If the device has not met these new standards in time, the device will be taken from the market and consumers may face shortages. This deadline also marks when all new and current content must be localized and translated for distribution across all EU member states.
How Does the New EU MDR Differ From Previous MDD Requirements?
The MDD is a directive, which is a legislative act that sets out a goal all EU member states must achieve. However, it is up to each country to determine exactly how to meet these goals and if they must devise their own laws to do so.
The MDR is a regulation, making it a binding legislative act that must be universally applied across the European Union. This means all EU member countries will have to abide by the same legislation.
As a whole, the new EU MDR is four times longer than MDD and includes some significant changes concerning medical device product classification, the clinical evaluation process, and identification systems.
Some key changes and new requirements include:
Every medical device must include a Unique Device Identification (UDI), which will be used to track devices through the supply chain and is required on all product labels.(Source: MDR, Article 27)
The definition of a medical device will be broadened to include cosmetic and non-medical devices that were not previously included. For example, under the new regulations, contact lenses, liposuction equipment, high-intensity electromagnetic radiation equipment, devices used for the sanitization of equipment, and active implantable technology will all be considered medical devices.(Source: MDR, Annex XVI)
Devices with substances that are absorbed by the body have been placed into a higher-risk classification system. (Source: MDR, Annex VIII, Chapter III)
Medical device manufacturers must conduct a clinical evaluation process of their current portfolio of products. Additionally, manufacturers will need to implement a Clinical Investigation Plan for their entire product line. (Source: MDR, Article 72)
The manufacturer must supply a complete set of “ the label or labels on the device and on its packaging, such as a single unit packaging, sales packaging, transport packing, packaging in case of specific management conditions… and the instructions for use in the languages accepted in the Member States where the device will be sold.” (Source: MDR, Annex II)
All medical device content must be translated into the official languages of the EU member countries where the device will be sold and distributed. (Source: MDR, Article 19)
How Does the New EU MDR Affect the Medical Device Translation Process?
New regulations require fresh and updated medical device translations. So what exactly does this mean for you?
Official Language Requirements
The previous MDD directive allowed the EU member states to create their own parameters around determining national language requirements when products are released to their local markets. As of 2024, the new MDR standards will require all content to be translated into all official languages of the countries they are being distributed in.
There have been multiple language additions to the EU since the MDD’s original publication. Since 1995,15 languages have been added, and as of 2023, there are a total of 24 official languages, with some countries having multiple official languages.
With this in mind, it’s important to adjust your translation needs accordingly, despite what languages you are translating content into today. So for example, if you will be distributing a medical device in Belgium, the content must be translated into the three official languages of Belgium; French, German, and Dutch.
One of the official objectives of the European Union’s Language Policy is to promote language mobility and intercultural understanding. These updated requirements will require medical device manufacturers to scale the amount of translated content provided with both existing devices on the market and devices about to be introduced. For some, this may significantly increase the number of languages and translations required for their content needs.
Device Classification Updates
The MDR is broadening the EU’s medical device classification system. This means medical device manufacturers need to determine what classification ranking their devices fall into, and produce content accordingly. Some devices, such as contact lenses and cosmetic medical equipment are now considered medical devices, so these manufacturers must now adhere to the new MDR guidelines and translate all applicable materials.
For those now requiring medical device translation services, Language Intelligence can help by providing native-speaking, professional translators with specific life science translation experience. These translators will understand the intent of your medical device content, and translate and localize it for accuracy in your target markets.
CE Mark Requirements
Under the MDD, translation wasn’t required until after the product was approved for the European Union CE Mark. Many medical devices require the CE marking before they can be sold within the European Union, and the CE marking “indicates that the product has been assessed by the manufacturer and has been deemed to meet EU safety, health, and environmental protection requirements.”
Now, with the MDR update, translated content for Instructions for Use (IFUs) and Product Labeling are required much earlier in the entire process. Translations are now considered elements of the overall technical report that is submitted by the manufacturer to the Notifying Bodies, to receive CE Mark approval.
For many medical device manufacturers, this change may impact their workflow, as translation needs to be considered far earlier in the process than it has been in the past.
Quality Management Systems
A large proponent of the MDR requires supply chain transparency, especially with the use of Quality Management Systems. As noted in MDR’s article 10 under “Cases in which obligations of manufacturers apply to importers, distributors or other persons”:
Distributors and importers shall ensure that they have in place a quality
management system that includes procedures which ensure that the
translation of information is accurate and up-to-date, and that the
activities… are performed by a means and under conditions that preserve the original
condition of the device and that the packaging of the repackaged device
is not defective, of poor quality or untidy.
This heightened focus on quality management has been put in place as a safeguard in ensuring all medical devices adhere to new MDR regulations, meaning it is imperative to only work with vendors with an established and credible Quality Management System, including your Language Service Provider.
Language Intelligence understands the importance of quality management, especially in such a regulated field that is the medical device industry. We hold the ISO 9001:2015 Certification as proof of how important translation quality assurance is to us as a company and will demonstrate compliance with all MDR updates and changes.
Content Translations Required for EUDAMED
The MDR is creating the European Union database on medical devices, EUDAMED. As one of the key details in the MDR update, EUDAMED will provide a picture of the lifecycle of medical devices as they are released in the EU. This central database will be used to process and store information on medical devices, provided by manufacturers, to enhance the overall transparency of the medical device market. With the help of EUDAMED, both patients and healthcare professionals will have access to information on every medical device on the market.
In order for this information to be accessible, all medical device content, primarily technical documents, for EUDAMED must be translated into all 24 of the European Union’s official languages. Additionally, all content must be able to be integrated into EUDAMED’s content management system (CMS) seamlessly. (Source: Functional Specifications for the European Database on Medical Devices, Chapter 4, Project Deliverables)
Language Intelligence understands that with these new MDR updates, medical device manufacturers will need to amplify the quantity of their translated content. We are able to provide high-quality, medical device translations, completed by professional, native-speaking translators with precise experience in the life science industry. For more information on how we can help ensure your life science translations are ready for the new MDR implementation, please contact us today.