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Your Questions about the EU MDR, Answered

On January 31, 2020, the United Kingdom left the European Union. And in May of 2020, the European Union will introduce the new EU MDR (Medical Device Regulations), which will modernize the process by which medical devices come to market. So for those who market or manufacture medical devices in the EU, this string of changes might seem confusing. Don’t worry; here, we’ll answer your biggest questions about the new EU MDR.  

If you’re a British company, you might be wondering: does the new EU MDR apply to me?

British companies are subject to the new EU MDR until the transition period concludes at the end of this year. Once this period ends, the UK could cease its implementation of EU MDR rules. This has not, however, been definitively announced. The EU IVDR, on the other hand, which will modernize the process by which in-vitro devices come to market in the EU, is not at all applicable to the UK or British companies.

So if the EU MDR does apply to you, how can you prepare?

We’ve actually had three years to prepare. The new EU MDR was published in May of 2017 with a three-year transition period to end in May of 2020. A year after its publication, only 55% of surveyed representatives in the field understood the new regulation. And now that the new regulation is creeping up on us quickly, it’s imperative that this percentage rise—soon.

You can prepare by doing a number of things, including:

  • Educating yourself on the new regulations (this could include reading up on regulation changes and attending workshops)

  • Performing device assessments to ensure they are up to par with new regulations

  • Ensuring you have the right documentation and that it is up-to-date. You will need post-market surveillance reports, safety update reports, and summaries of clinical performances, to name a few

  • Improving clinical efficiency

  • Investing in more advanced technology. Systems should improve compliance with the EU MDR as well as mitigate risks.

Here is the most important information you should know regarding the new EU MDR:

  • All medical devices will need a UDI (Unique Device Identification) Code by May 26, 2020. If your device falls under Class IIa/b or Class III, its UDI will need to be recorded, indexed, and registered on EUDAMED

  • Manufacturers of Class I products are required to collect and save product data.

  • Manufacturers are obligated to invest in technology that ensures the fast and accurate application of traceability coding to products/packaging at the individual item level.

Lastly, you might be wondering what will happen if you don’t comply with the new regulations. Compliance failure will result in the withdrawal of your device from the EU market.

The three-year transition period was provided to ensure that manufacturers had ample time to comply with new regulations. While the new regulation will come into effect in about three months, there is still time to get your ducks in a row. For further questions, contact us today. Source:

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