MDR (Medical Device Regulation) for the EU (Europe)
The new medical device regulation goes into effect May 26, 2021 this year. This is a high level summary of what you're up against. It is four times longer and has five more annexes than the medical device directive.
The word safety appears 290 times compared to 40 times. You're going to be required to rationalize your portfolio and perform a global impact assessment on your devices. There's new conditions that require you to look at your legacy products, and most of your existing products will have to be recertified.
You're going to have to update your clinical data, technical documentation, and the labeling is changing. There's a unique device identification that has to be on your label throughout the supply chain. The definition of medical device is going to be broadened into nonmedical devices and cosmetic devices that weren't covered by the medical device directive before. You're going to have to generate and provide more clinical data.
There's a porthole that they're creating that as a manufacturer, you be required to report incidences, injuries, and deaths. You're going to have to revisit your core processes, your quality management system, your risk management system, and if you don't already have it, post market expectations is going to be a requirement of the new regulation.
They're reclassifying most medical devices and coming up with new classifications for reusable surgical devices. And if that's not enough, the IVDs are being broken into four risk classes now, and 90% of those are going to require a notified body for your certification, versus 10% in the old directive. We're here to help you!
Since 1988, Product Safety Consulting has been providing product developers and manufacturers with expert advice and testing services, so they confidently secure product safety and regulatory compliance in the least time, and for the least expense. From consumer products to lighting fixtures, to motor controllers and medical devices, we have helped customers in over 35 countries obtain certifications for more than 3,000 products. We provide Product Safety Consulting and UL Testing for all types of products.
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