On May 25, 2017, two new European Union regulations on medical devices were adopted. These new regulations may require close partnership with localization suppliers to ensure conformance.
They impact technical documentation requirements significantly in many cases, while new unique device identifier (UDI) requirements have and will continue to impact labeling layout, making it essential that new designs take localized text expansion into account. In addition to technical documentation, applications for clinical investigation and analysis of serious incidents/corrective actions will most likely need translations.
The new regulations are extensive. The English regulations’ text — with multiple annexes — runs to over 180,000 words, and while it is available in 23 other EU languages as well as English, remains a bit daunting to interpret. Here we provide an overview of the regulations as well as how this will affect translation overall.
•Regulation (EU) 2017/745 on medical devices amends Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, while repealing Council Directives 90/385/EEC and 93/42/EEC.
•Regulation (EU) 2017/746 on in vitro diagnostic medical devices repeals Directive 98/79/EC and Commission Decision 2010/227/EU.
Classification changes
Medical device classification has undergone changes based on risk, resulting in an increase to the number of devices that are to be checked by notified bodies before market entry. Manufacturers need to demonstrate that their devices meet requirements through a conformity assessment. The regulations now cover many products that were previously not covered. For example, aesthetic products like colored contact lenses now need to comply with the stricter controls. Based on a risk matrix outlined in Annex VIII of the medical devices regulation, and VII of the in vitro diagnostic regulations, the conformity assessment can potentially be self-assessed. This is the case for some low-risk Class I devices such as spectacles, or certain Class A in vitro diagnostic medical devices such as specimen receptacles. Otherwise, conformity should be assessed through a notified body. The result of a passed conformity assessment is a declaration of conformity, meaning that manufacturers can use the Conformité Européene (CE) mark.
Manufacturers will need to analyze whether their devices have been reclassified and update their technical documents, in particular file dossiers for conformity assessments accordingly. This will most likely affect all target languages and therefore translation and localization changes will need to occur. It is critical for you to discuss these changes ahead of time with your language service provider (LSP) to help plan the best strategy to accomplish regulatory compliance throughout your languages and regions.
While there will be additional workload for notified bodies and LSPs, the result of the new regulations is not all about additional red tape. For example, where clinical trials take place in multiple member states, they are subject only to a single coordinated assessment instead of individual national assessments. This can help get products to market quicker and improve the timing of feedback from the field.
UDIs and EUDAMED
An important aspect of the new regulations is their attempt to spawn greater transparency through the creation of a common European database for medical devices called EUDAMED, which will be available in all official EU languages. This will operate by registering unique device identifiers (UDIs) for every device in a process that will be familiar to manufacturers that have entered the US market in recent years. UDIs and EUDAMED make up a system that allows for traceability and recall, as well as easy, centralized access to product information and reporting.
Manufacturers will need to integrate technology in order to maintain updated UDI-related information such as post-market clinical investigation data and performance studies. Manufacturers also need to include a UDI on every product label, meaning that label design needs to be altered to reflect the new requirements. This aspect can require planning, as label space is already in short supply, particularly where translations are needed. Existing Class I and Class II device deadlines for UDI final rule have come and gone, while Class III devices are scheduled to be completed by September 24, 2020.
One of the benefits of the new system is that once a manufacturer’s products have been assigned a UDI, and the relevant information has been supplied to EUDAMED, device registration is done at the EU single market level, making multiple national-level registrations a thing of the past.
Quality and risk
Both of the new regulations require manufacturers to demonstrate an effective quality management system containing a risk-based approach to decision-making and especially the monitoring of any tasks delegated to third-party suppliers. The current ISO standard for medical devices, ISO 13485:2016, is not explicitly required by either regulation, but as the recognized industry standard, it is generally thought to be both robust and compatible. Should any harmonization be required, your certification body is the best point-of-contact in order to ensure that your implementation of the ISO 13485 standard fits any new requirements.
The regulations do set out the requirements for the selection and effective control of suppliers. The ISO 13485:2016 standards catalogue explains that “The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system.”
This means that a manufacturer can help to mitigate potential risks by ensuring that its supply chain is also ISO 13485 certified, including any LSPs used.
The regulations emphasize risk management and continuous safety improvement throughout a product’s life cycle. The likely result of this is a much heavier burden on manufacturers, which will need to continually report on an array of surveillance areas with the aim of identifying corrective and preventive actions on an ongoing basis.
There are new requirements that manufacturers will need to implement, too. Section 1 of Chapter VII of both regulations detail new post-market studies that are needed: Periodic Safety Summary reports (PSURs) analyze post market surveillance data, while Post-Market Clinical/Performance Follow-Up (PMCF/PMPF) are a framework for the continuous updating of clinical/performance evaluations.
Dates to know are:
•May 26, 2017: The official entry into force of the medical device regulation (MDR 2017/745) and in vitro diagnostic regulation (IVDR 2017/746).
•November 26, 2017: Notified bodies may apply for designation under MDR and IVDR.
•March 26, 2020: EUDAMED will go live.
•May 26, 2020: MDR date of application.
•May 26, 2022: IVDR date of application.
•May 26, 2024: The older AIMD, MDD and IVDD certificates become void; no devices may be placed on the European market under these certificates.
•May 26, 2025: After this date, no devices may be put into service in Europe using AIMD, MDD and IVDD certificates.
Who else is affected?
In addition to the increased responsibilities for manufacturers and notified bodies, importers and distributors are now also burdened with significant additional legal and oversight requirements:
Importers and authorized representatives now have responsibility and legal liability for checking CE mark and conformity assessments, labeling and so on, as well as the requirement to decide whether a product complies, and potentially refuse to import a product where they deem that it does not meet the regulations. The new requirements go far beyond the traditional role of importer, meaning that importers need to look carefully at the regulations in order to fully understand their exposure to risk, as well as to restructure agreements they already have with manufacturers so that they reflect their new oversight responsibilities.
Distributors too face an increased legal liability for products they store and transport, and will need to take similar steps to ensure that their exposure to risk is controlled and existing contracts are updated.
Localization and beyond
Make sure that your localization partner fully understands the implications of these regulations and is able to work with you on how to implement the changes that your company decides are relevant to your products. LSPs are certainly able to provide general direction regarding language requirements for different markets. However, any final decisions about which languages device information will require (for instructions for use and labels, for example) will need to be verified by the Competent Authorities in each member state. In line with existing e-labeling directives, medical devices, including in vitro diagnostic medical devices, intended for professional use can continue to be supplied in an electronic format.
Supply chain transparency and risk management will mean that manufacturers will need to be able to rely on LSPs that can demonstrate robust quality methodologies — likely through certifications such as ISO 13485:2016. No matter what, involving your LSP early and often is the best plan of action.
These regulations involve some big changes to how the medical device markets have operated. The regulations affect multiple parts of the supply chain, with the eventual aim of increasing safety and reducing risk.
During the transition periods of three years (MDR) and five years (IVDR), it is foreseen that there will be additional legislation, too, which will help to clarify any areas where there might currently be doubts. It is incumbent upon all affected parties to stay up to date with evolving regulations while adjusting to the new regulations.
All affected parties are advised to begin building strategic planning teams from all areas of their business to fully analyze the impact the regulations will have to their business. This clearly means regulatory, compliance and quality teams, but will also need to include stakeholders from other areas of the business including marketing, operations, IT, authoring teams, labeling and key suppliers, including publishers and LSPs. Together, these steering groups will need to build a collaborative plan with their partners for the successful implementation by performing an initial gap and risk analysis, portfolio assessments for reclassifications, thorough supply chain analysis, return on investment calculations and budgeting for the transition to the new rules.
