Is your organization ready for the upcoming regulatory changes affecting medical devices and clinical trials in the European Union (EU) and the United States (U.S.)? Both the EU and the U.S. have recently started implementing new rules to make clinical trials more accessible, transparent and diverse. The EU is also putting into place rules for medical devices that focus on patient empowerment and safety. Communication is key to both, and compliance will require translated materials that reflect the linguistic diversity of the region. Our team is here to help by supporting your efforts through language solutions, including translation in multiple languages.
Here’s a primer on what the new rules mean for organizations in these industries, and our recommendations for managing these regulatory shifts.
European Union: Transition Period Ends for Clinical Trials Regulation (EU) No 536/2014 (CTR)
In January 2022, the Clinical Trials Regulation became effective for all new clinical trials in the EU. This regulation requires clinical trial sponsors and contract research organizations (CROs) to submit clinical trial information into a new centralized database called the Clinical Trials Information System (CTIS). The regulation also streamlines review procedures and harmonizes the EU clinical trial application process.
The CTR also introduces new documentation and language requirements:
- Clinical trial information and data must be publicly accessible in the EU database.
- Plain Language Summaries (PLS) written for laypersons should be available in the official language of each country where the study was conducted.
- Added language requirements may apply in some member states.
The regulation included a one-year transition period, which expired in January 2023. Organizations with active trials that started before that date have until January 31, 2025 to bring those trials in line with the updated standards.
During the past year, our team has collaborated with our clients to ensure that they are compliant with the new submission processes by introducing agile translation processes to ensure that tight deadlines are met, while ensuring top-notch quality and accuracy.
Here are some steps we recommend to ease this transition:
- Familiarize yourself with the Clinical Trial Application processes using the CTIS portal.
- Double-check your standard operating procedures for compliance.
- Ensure that your clinical trial supplies follow new Investigational Medicinal Product (IMP) labeling requirements.
- Be ready to follow public disclosure guidelines and Requests for Information.
- Streamline your own workflows to meet shorter timelines for validation, assessment and approval.
Transition Period Extended for Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR)
In February 2023, the European Parliament voted to extend the transition period for the Medical Devices Regulation (MDR) to avoid a shortage of life-saving medical devices in the region. They also voted to allow devices already on the market to continue to be sold until they expire without meeting the new standards.
Despite the vote, manufacturers should start moving toward compliance as soon as possible. As Erik Vollebregt, a partner at Axon Lawyers, explained in Regulatory Focus, “The amendment is not intended to give industry more time but is intended to only give notified bodies more time to process the huge pile of applications that had amassed towards the end of the grace period. Any devices company that misunderstands this is making a critical mistake and will miss its launch window for extension, inevitably leading to a period of not being able to place devices on the market in the Union until MDR CE has been obtained.”
Translation Requirements Under the MDR and the IVDR
One of the goals of the MDR is improving patient safety. The focus of the updated requirements is to empower patients with usable and understandable product information and instructions.
Here is a breakdown of the language requirements in the MDR:
- EU member states determine their own MDR language requirements which affect medical device labeling, packaging, instructions, and other written patient information materials.
- Manufacturers must meet MDR language criteria for each market the device will be sold in.
- Medical software graphic user interfaces (GUIs) must be in the official languages of the regions the product will be marketed in.
The In Vitro Device Regulation (IVDR) requirements are similar and include:
- Information intended for end-users must be translated into the official Union languages determined by the member state(s) it will be available in.
- Translators who are experienced in medical translation must be utilized to ensure the quality and accuracy of translations as well as patient safety.
- Device information must be made available via the manufacturer's website in multiple languages where appropriate.
- Other documentation, such as technical documentation, may be required upon request from a competent authority in whichever official EU language the member state specifies.
- Authorized representatives may also receive documentation requests from competent authorities. They will need to make pre-existing arrangements with manufacturers to handle translations.
- The EU declaration of conformity must comply with relevant language requirements wherever it is sold.
- The field safety notice must be issued in the official language or languages assigned by the member state(s) where the field safety corrective action is taken.
To thrive under these new regulations, your organization needs a fast, flexible process for handling translations. It’s crucial to work with experts in the field who understand both the science involved and the relevant compliance issues.
United States: Public Law 117-328 requires diversity in clinical trials
Public Law 117-328, the omnibus spending bill enacted in December 2022, requires diversity action plans for all clinical trials used by the Food and Drug Administration (FDA). Companies conducting clinical trials should use the recently issued draft guidance to plan for its implementation.
Your business can ensure compliance and improve trial data for diverse populations by implementing this guidance in a timely manner.
Culturally and linguistically appropriate communication is crucial to attracting and retaining diverse research volunteers for your trials and ensuring that trials are ethical. More than 80% of clinical trials struggle to recruit enough volunteers, and marginalized communities are often reluctant to participate.
Researchers from Janssen Research and Development recently noted that sponsors must be responsive to community feedback, which may involve translating trial materials.
ULG’s experts recommend that companies partner with community organizations and language service providers who have the cultural expertise and connections to ensure clear communication and engagement.
How ULG Can Help You Navigate a Shifting Regulatory Environment
Our team is knowledgeable about the medical device industry and are here to help you meet global regulatory requirements. We’re a one-stop shop, enabling efficient, centralized processes. We use state of the art tools and technology including Octave, our translation management system, to ensure quality and efficiency.
To learn more about how we can help your organization, contact us today.