Regulations that govern the life sciences industry are centered around one primary goal: ensuring that medical devices are safe to use. While it can seem challenging to adhere to regional requirements for these devices, following international standards can ensure that medical devices are compliant within various regulatory requirements around the world. These standards help medical device manufacturers avoid errors and improve the safety of their devices.
This article continues the discussion of how the life sciences industry can ensure quality translations after exploring the risk of improper translations in part one of this series. This article’s primary focus is on the medical device industry and a subsequent article will focus more on the pharmaceutical and biotech industries.
Complexities of Medical Device Regulations in the EU
The European Union has stringent medical device regulations. The most recent version (MDR 2017/745) went into effect in 2020, which was preceded by a transition period to allow medical device companies to prepare for the upcoming changes. Still, it is worth revisiting what this regulation means for translation and localization of content for medical devices (packaging, labeling, IFUs, product training, etc.).
In the current version of the EU’s medical device regulations (EU MDR)1, translation plays a larger part than ever before. While EU Member States were previously allowed to choose their own language selection, the current version requires all medical device content within the EU to be translated into all 24 official languages of its member states. For some medical device companies, that greatly expands the number of languages that require support. It also requires companies to provide translations of labeling and instructions for use to be submitted for review to the Notifying Bodies.
This new regulatory framework also requires companies to have transparency regarding quality standards and risk management. A language service provider (LSP) will need to support medical device companies regarding this requirement. This includes leveraging content and translation management systems to ensure accurate global changes, consistent translations, traceability of work, and cost-efficient processes and provide a Certificate of Translation Accuracy.
Improving Quality with International Standards
Using international standards to ensure confident and high-quality products is not a new phenomenon. For the medical device industry, ISO 13485:2016 demands that companies demonstrate their quality management system’s implementation, maintenance, and effectiveness. Certification can be obtained through the review of independent and extensive audits.
ISO 13485 certification also demonstrates that medical device manufacturers have extensive knowledge of medical device regulations; this certification can show compliance with EU MDR. This is the same for suppliers – including LSPs – that serve the medical device industry.
Reducing Errors and Risk
The purpose of the EU MDR and ISO 13485 is to ensure quality and safeguard the patients and doctors around the world that will use these devices. Failure to meet these quality, safety, and regulatory standards could result in misuse, injury, or worse. Our last blog discussed how mislabeling of a prosthetic device resulted in 47 cases of the device being implanted incorrectly at a German hospital. These types of errors can lead to dangerous, even deadly outcomes for patients, as well as financial penalties and ultimately non-compliance that could make the device unmarketable.
Since these regulations affect medical device labeling, packaging, instructions, and other written patient information materials, medical device manufacturers must find a reliable LSP that can ensure quality. Considering the different types and sources of this information and all the revisions to existing technical documentation required by the new regulation, your LSP must be able to interact with client-based Content Management Systems and have an effective Translation Management System to ensure accurate global changes, consistent translations, traceability of work and cost-efficient processes. After all, the LSPs supply much of the final communication that reaches doctors, technicians, and patients around the world. To thrive under the EU MDR, medical device companies need a fast, flexible process for handling translations and a partnership with experts in the field who understand both the science involved and the relevant compliance issues.