It’s not long until the EU’s new medical device regulations come into force – how ready are you?
When it was announced back in 2017 that the EU would be changing how it regulates medical devices in 2020, companies seemed to have plenty of time to adjust to the new way of doing things. But with 2020 fast approaching, what do these new regulations mean, and most importantly, are we ready?
What do the new regulations include?
As technology is evolving faster than we could ever imagine, the number one aim of these new regulations is to bring an outdated system into the modern world. Just to briefly describe what’s on the horizon, here are some of the key points of Regulation (EU) 2017/745 and Regulation (EU) 2017/746:
- Stricter ex-ante control for high-risk devices
- Changes to the way Notified Bodies are overseen
- Including certain aesthetic devices
- New classification systems for in-vitro diagnostic medical devices
- Introducing an implant card
- Reinforcing the rules of clinical evidence
- Improving post-market surveillance
- Improving coordination mechanisms between EU countries
Why have these changes been made?
The PIP breast implant scandal that hit the headlines a few years ago highlighted the weaknesses in the legal system governing medical devices. As patient safety is one of the EU’s top priorities, they introduced these new measures to ensure that something like this would never happen again.
What does this mean for translation?
Although translation is covered in just a fraction of the new regulations, it’s still there all the same. In order to be compliant, your medical device documentation, labels, IFUs, and anything that demonstrates conformity will need to be translated, even if it’s in electronic format.
Another important fact to consider is that part of the regulations govern the supply chain, which is why it’s so vital to use a translation provider that’s well-versed in medical device regulations. They’ll need to show that they’re certified, and have an effective QMS system in place.
If you’re a medical device manufacturer and would like some help getting your products ready from a translation point of view, please feel free to get in touch – we’ll be happy to help!