EU MDR Delayed to Prioritize Fight Against COVID-19
On April 3rd, the European Commission adopted a proposal to delay the application of the EU MDR by one year, to May 26, 2021 in order to allow “Member States, health institutions and economic operators to prioritize the fight against the coronavirus pandemic.”
What does this mean for global healthcare?
This is a positive outcome for healthcare systems across the EU, as it provides for uninterrupted access to vital life-saving devices.
Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “Shortages or delays in getting key medical devices certified and on the market are not an option right now. The Commission is therefore taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic.”
Stella Kyriakides, Commissioner for Health and Food Safety, added: “Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided.”
What does this mean for manufacturers?
The delay is also a positive outcome for device manufacturers. First, it obviously means more time to become compliant. According to industry polls, around 40% of manufacturers weren’t going to be fully compliant by the May 26 deadline. Now there’s enough time to get processes and documentation in shape, including preparing all required translations.
Second, it means more access to notified bodies. There are only 11 MDR-designated notified bodies today. The extension should allow for more notified bodies and increased overall capacity.
Third, it means that manufacturers are able to prepare multilingual documentation for all of their target markets in the EU. There’s an enormous volume of documentation under the MDR that must be translated into the official language(s) of each country. Many companies were prioritizing languages in order to meet the deadline, but now there’s sufficient time to prepare documentation for all intended EU markets.
Stay current & keep in touch
For a refresher on the complex EU MDR language requirements, take a look at our recent webinar that we co-produced with RAPS.
If you have any questions about translating your documentation or MDR compliance in general, please contact us directly.
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3 Tips to Help Keep Remote Employees Engaged and Motivated during COVID-19
For multinational organizations that have switched to a remote work setup (like Morningside), maintaining an off-site international workforce raises new management and HR challenges – with communication chief among them. As companies reinvent their way of doing business during the COVID-19 pandemic, it is critical to maintain engagement with home-based personnel. Here are three things you can do to ensure your remote employees feel connected and motivated during these trying times:
Provide interpretation support for online phone calls and video meetings
While it is unsafe to hold in-person meetings, business can run as usual with the use of online phone calls and video meetings. Platforms like Skype, GoToMeeting and Zoom (just to name a few) will support phone or video meetings with colleagues or clients based anywhere in the world – as long as they have an internet connection and no language barriers.
When you’re conducting online business meetings with multilingual participants, it’s important to ensure everyone can understand one another. If there is any risk of a communication barrier, a professional interpreter can make all the difference in the world. During COVID-19, you can rely on Morningside for video remote or phone interpretation services across a wide variety of industries. Our global network of 8,000+ linguists are experts in dozens of technical fields and subject areas, including legal, finance, life sciences, manufacturing, and consumer products, and our quality management system is ISO-9001, ISO-13485, & ISO-17100 certified.
Provide multilingual eLearning courses for employee onboarding & continuing professional development
With personnel working off-site, a genuine opportunity arises to connect with your employees by reinforcing and enhancing critical skill sets via online training and targeted eLearning assignments. Doing so will increase employee engagement, whether it’s for onboarding new team members or providing new learning opportunities for existing employees. Luckily, Morningside is an expert at helping companies develop and deliver successful multilingual eLearning courses for transnational workforces.
Note: There are two ways to provide eLearning modules – live courses or self-guided programs. When companies prepare self-guided eLearning models — which can include everything from PowerPoint presentations and audio scripts to video content and captioned graphics — Morningside will work tirelessly to ensure accurate translation and localization, seamless integration, and user-friendly deliverables that provide the same user experience as the source content. For live sessions, our simultaneous interpreters help present information and graphics clearly and accurately. Audience questions receive the same treatment, allowing for a lively back-and-forth that helps keep employees engaged.
Encourage virtual team coffee breaks or water cooler chats
Social distancing is necessary, but that doesn’t mean we should completely change our ways. Chatting over a cup of coffee or by the water cooler can play an important role in your employees’ happiness and satisfaction at work. So while we can’t take physical breaks together, employers should encourage virtual team breaks where groups gather on Skype, Zoom, or GoToMeeting just to talk. Breaks should be scheduled and timed, but obviously no agendas need to be planned. This is a time for people who are used to spending so much time working right next to each other to catch up and chat in a stress-free environment.
An opportunity not to be missed
Interestingly, recent research reports that people who work at home have been found to be more productive than those operating in a conventional office environment — and that remote workers even put in extra time (the equivalent of 1.4 extra, unpaid workdays each month, or 16.8 days per year). With that in mind, employers can choose to look on the positive side during these restrictive times, and focus on the value that increased multilingual support will bring to employees and clients around the world. For more information on Morningside’s remote interpretation or multilingual eLearning services, please contact us.