The annual RAPS Regulatory Convergence, held in beautiful Vancouver this year, was an exciting opportunity for the Lionbridge Life Science team to meet with medical device and pharma clients and get updated on how the industry is responding to the changing regulatory landscape. Keeping abreast of regulatory requirements is key to our commitment to be the best possible compliance partner for our Life Science customers.
This year, the buzz at RAPS was notably strong from the medical device attendees. As the 2020 deadline for implementation of the EU MDR fast approaches, our MedTech partners are in the process of preparing for new safety, performance, labeling, and post-market surveillance requirements. The conversation at RAPS confirmed our impression that manufacturers still have many questions and concerns around how to interpret the stricter requirements enforced upon them and upon the Notified Bodies that perform the conformity assessments. The coming changes are major—including new device classification rules, stricter requirements on clinical performance data, implementation of the UDI system for medical device traceability, and public access to clinical and safety performance through the European database EUDAMED.
According to a recent survey from KPMG and RAPS, 41% of medical device companies “have yet to evaluate the long-term maintenance needed to comply with the looming regulation.” Most respondents indicated a lack of both understanding of the legislation and a strategy to meet its requirements.
We know there will be ramifications of the new regulations in the EU that our clients aren’t yet thinking about. The UDI system and labeling formatting requirements pose obvious challenges for medical devices. What’s more, both the EU MDR and the new EU Clinical Trial Regulation focus on transparency, which means product information, labeling, and publicly disclosed information on research results need to be delivered in language that is clear and understandable to the intended user, the patient, and the general public. That yields a sizable burden for manufacturers, but it’s one they don’t need to shoulder alone.
Although many of our customers have already implemented transparency policies, disclosing information on product performance, safety, and research results is a delicate task for both medical device manufacturers and clinical trial sponsors. In addition, transforming scientific results into plain language that the public can readily understand poses particular challenges: concerns include misinterpretation of performance or safety claims, risk of promotional or biased language, and skewed or incomplete results in abbreviated summaries. How can medical device manufacturers and clinical trial sponsors best preserve the scientific validity of product performance or research results while making information accessible to a non-scientific audience in a local language? Partnering with a trusted linguistic service provider with expertise in both scientific and plain language content is key.
We invite our clients to have a conversation with us about how we can help manage their language needs and challenges as they face the new EU regulations. We’re eager to discuss how we can help. We have identified at least three areas where we can alleviate pressure for medical device clients and clinical trial sponsors to comply with regulations:
- Translations of all content related to medical device clinical investigations for class III and implantable devices, bolstered by our solid track record within global clinical trials for human medicines.
- Labeling changes and formatting challenges to comply with the new UDI tracking system and requirements regarding information supplied with each device.
- Translations of content to be publicly accessible for Medical devices and clinical trials in plain, local language via the EUDAMED and EU clinical trial databases.
Our main takeaway from RAPS 2018? Come at us, 2020—we’re ready for you.
Learn more about our Life Science team and start a conversation here.