Going into effect in 2021, the tighter regulations in the European Union have been a major challenge for medical device companies. With worries growing that medtech companies would pull products out of the EU because of their inability to comply on time with the MDR, the EU’s government approved extending deadlines to get device designs and quality systems certified to as late as 2028 for some devices.

“The scale of this transition to a new regulatory framework has proven to be a challenge for medical device manufacturers and the notified bodies who certify them. Given that, Inspire is pleased to reach this critical milestone,” Andreas Henke, Inspire’s EVP and managing director in Europe, said in a news release.