As the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) transitions to a new post-Brexit regulatory framework, it has announced that medtech companies will get extra time to comply with regulations. This is good news for the industry, which has faced some troubles in the leadup to Brexit.
The new regulatory framework will place importance on patient safety and will see the MHRA transitioning from a product-based to a lifecycle-based regulatory agency. This transition has not been without its challenges, but the agency is determined to make it a success. Device makers now have an extra three or five years to comply with CE Marking requirements, depending on the type of device. This gives them more time to familiarize themselves with the new rules and make sure their products comply to ensure a smooth transition to the new framework and minimize disruptions to their business.
This will affect companies in the U.K. because the CE Mark will no longer be valid for products placed on the market in Great Britain from July 1, 2023. To send their devices to that market, companies must obtain a UKCA Mark. The process for doing this is still being finalized, but it’s expected that self-certification will continue for low-risk Class I devices. This means medtech companies will not have to go through the lengthy and costly process of Notified Body certification.
With its focus on patient safety and dedication to ensuring a successful transition, the MHRA remains a crucial player in global medtech regulation. If you are a medtech firm in the U.K., you must keep up to date with the latest MHRA announcements and guidance. This will help make sure your products remain compliant and allow you to take advantage of possible extra transition time.
If your company is U.K.-based, compliance with its regulations is essential for your products to remain on the market. MEDIcept can help you navigate the complex U.K. regulatory landscape, ensuring your products are compliant and minimizing your business risk. With our experienced team of regulatory consultants, we can assist you in securing a smooth transition to the new MHRA framework. With years of experience in U.K. and global medical device regulation, we are your partner for a successful transition to the U.K.’s new regulatory system. Contact us today to find out more about our regulatory services and how they can help your business under the post-Brexit framework.
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MEDIcept is an international consulting firm offering a full portfolio of services to the medical device and IVD industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.