The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, is anyone ready? Well, let us have a look.
Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy.
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
Class I device manufacturers need to keep on top of new classification rules to avoid loss of market share under the close approaching EU MDR deadline.
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
Medical devices economic operators need to act fast to mitigate impacts of the UK withdrawal of EU in March 2019.
Industry experts share advice that could influence company success.
Fewer resources and more requirements are hindering the process.
With decreasing prices and increasing regulation, many UK medical device businesses are looking to emerging markets for growth. However, compliance issues are also problematic in those territories, according to a recent study from life science consulting firm Maetrics.
The most important part to remember about this recommendation document for unannounced audits is that it not only applies to medical device manufacturers, but also significantly includes their suppliers and subcontractors.