Brexit’s new rules and market access implications Staying abreast of market entry requirements is more important than ever as the regulatory landscape in the U.K. and EU finally reached an agreement. Here’s what we know today: Following the United Kingdom’s (U.K.) departure from the European Union (EU) on Jan. 31, 2020, the EU and U.K. jointly agreed on a transition period that ended on Dec. 31, 2020. During the transition, the U.K. maintained status-quo for businesses and consumers, which means that the EU still recognized U.K. notified bodies, and manufacturers could sell CE marked products into the U.K. market until Dec. 31, 2020. On Dec. 24, 2020, the United Kingdom and the European Union have agreed a Trade and Cooperation Agreement. The U.K.-EU trade Agreement contains new rules for living, working and trading together and entered into force on Dec. 31, 2020. The full Agreement is 1,246 pages and is available here. The deal secures tariff-free access between EU and U.K. markets, but does not change the compliance process, so the UKCA and the conformity to the U.K. Legislations remain mandatory for placing goods on the market in Great Britain. The new rules apply from 11 p.m. Dec. 31, 2020.…
Up-to-date information on regulatory changes, deviations, exceptions and extensions that may impact access to your target markets The regulatory landscape is changing rapidly and staying on top of market entry requirements is more challenging than ever before. With new information emerging daily, having the most current insights can help you better manage product certifications and approvals in uncertain times. Visit UL Website frequently to learn the current status for: Obtaining certifications and renewal acceptance Regulatory deviations, exceptions or extensions Contact details to access information about smaller markets and specific certification status Updates will be made frequently and as quickly as information can be obtained from regulators. If you have questions on specific projects or for countries not listed here, please contact your UL project handler or contact us to reach one of our experts. Click here to gain up-to-date information on regulatory changes, deviations, exceptions and extensions that may impact access to your target markets.
The safety of medical devices extends beyond electrical safety so that the people who are using and applying the medical device must be able to do so safely and effectively. There are several terms commonly used to describe the science behind incorporating effective and safe use into a device’s design including 'usability,' 'human factors engineering' (HFE)” and 'ergonomics.' HFE has been added to regulatory requirements to: reduce medical device use error create more operator friendly and intuitive devices reduce the training costs for both manufacturers and end-users. Visit our main page for clear and educational resources and guidance, including: Standards for Human Factors Engineering FDA Requirements Articles & Published book resources Podcasts and recorded webinars Visit the page here Contact the European team to learn more
Safety is the heart of our mission and drives every decision we make. While the evolving coronavirus situation has presented new and unprecedented challenges, UL is well prepared and responding with the best interests of our employees, customers and communities at the center of our decision making and processes. As we take steps to help ensure the health and well-being of our people, we balance those with the needs of customers around the world. Many of our employees have been asked to adopt remote work arrangements, reduce travel and face-to-face meetings, and minimize participation in non-essential sponsored events and public gatherings. At the same time, we continue to meet client needs by activating local and global business continuity plans. This enables us to move client engagements forward wherever possible while also maintaining a safe and healthy work environment. We know that businesses and consumers around the world depend on your products and services. Adapting our processes provides support in new ways while delivering on our brand promise. UL has several complimentary resources available to help you address challenges created by the novel coronavirus. Please consider reviewing the following: The myULTM portal, or other client business portals, for up-to-date project information…
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