The countdown clock to the application of new EU Medical Device Regulation (MDR) started its three year life in May 2017.
Understanding the changes, let alone navigating them successfully to prepare for compliance in May 2020 is no small task.
Thankfully, the UK regulatory agency (MHRA) has produced a guide to help you get to grips with what has changed and what you may need to do to get ready for a smooth transition in 2020. After a detailed review of the MDR, we published the 15 things you need to know.
Unlike many other regulatory changes in the EU and US, there will be no “grandfathering” of existing medical devices under the MDR, so we strongly recommend starting your preparations sooner rather than later. If you’re developing or marketing a Class 1 medical device, you should read about what’s happened with the self certification route too.
And with the ever decreasing pool of Notified Bodies available to work with for the higher risk devices, you’ll probably need some guidance and help before you reach out to one of the few remaining bodies to assess your product against the MDR and (re)certify your CE marking.
We’re always here to provide reassurance, guidance and a helping hand, to ensure you don’t do too much, or too little. We ensure you only do what you need to.
Get in touch today, make the most of the time you have left on that clock.
Read more on this topic with these related posts: