It’s no exaggeration to say that the European Medical Device Regulation (EU MDR) is one of the most impactful pieces of legislation to hit the industry in decades. It was established to ensure a robust, transparent, predictable and sustainable regulatory framework for medical devices in the EU, improving health and safety while supporting innovation.
But it also means a significant change to the way organizations approach translations. What will the impact of MDR be on packaging and labeling in Europe?
The EU MDR replaces two previous directives, the Active Implantable Medical Devices Directive and the Medical Devices Directive. Both of these helped create the single market for medical devices in Europe, but were flawed because different European countries interpreted and implemented them in different ways.
The new directive will better identify medical device products and improve transparency through standard data and technological advances. Furthermore, databases established under the new EU MDR will contain more comprehensive data on the devices themselves, including Unique Device Identification (UDI) data, and data on all the economic operators associated with those devices. There is also a greater expansion of scope, with products that have an aesthetic or non-medical purpose now included. Such devices are similar to medical devices in terms of risk profile, and it was felt their inclusion would be a fairer and safer approach.
Although the EU MDR came into effect on 25 May 2017, there is still some leeway for medical device manufacturers. They will have three years from that date to transition to the MDR, which leaves many manufacturers currently in the middle of preparing for this – updating technical documentation and tightening processes to ensure compliance with the new regulations.
Translations and MDR
Translations have long been an important element within the medical device industry, but in the global culture in which we live and work, that importance has grown, especially in a common market with as many different languages as the EU.
The new regulations specify translation requirements associated with the marketing of medical devices in the EU, and apply to packaging, labeling, instructions for use, and anything else associated with medical devices. Previously, language requirements were the responsibility of each member state, but now there is a requirement that labeling must be in the national language and ‘clearly comprehensible to the intended user or patient’. The packaging and labeling covers virtually everything written on a device, and both the inside and outside of the packaging. It applies to consumer medical devices as well as more complex devices, so is no small undertaking.
This is a significant challenge for manufacturers. For any device maker selling in smaller markets they now need to either provide that ‘clearly comprehensible’ labeling or exit the market. Compliance with MDR is absolutely essential if the manufacturers are to continue to sell their products, but even if we focus for now only on instructions for use, these are multilingual documents that may require translation into as many as 30 languages.
AMPLEXOR and medical devices
AMPLEXOR has a rich history in working with life sciences firms on translations, and has already begun work with several medical device manufacturers in helping them with their preparations for the MDR Directive. Additionally, the new MDR has established a similar system to that of UDI Rule by FDA (2013) which requires manufacturers to include the UDI on device labels and packaging, meaning AMPLEXOR also has experience adopting new regulatory requirements when it comes to translations for medical device companies.
AMPLEXOR knows exactly what content needs to be translated, particularly important given one of the principle challenges when implementing MDR is to identify what additional content is required for translation.
Because the new MDR requires considerably more comprehensive data on the devices, product data management must be vastly improved to have an impact on the translation outcome - only consistent technical documentation can lead to a superior quality translation. AMPLEXOR can manage the varied and multiple data formats to support the medical device companies in translating the content from whatever systems or platforms it originates.
MDR is essentially about the strategy and technologies to automate content management. AMPLEXOR is an experienced partner in the centralized translation management, automating labeling content and translation, and can fully support localization strategies for medical device companies.
Failure to produce accurate, MDR-compliant labeling and other patient information could delay market entry, or even necessitate a product recall. To learn more about the MDR Directive, please click the link below.
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Romuald Braun 2min read 19/11/18