Following the recent news (Wednesday 18 September) that Biotronik has obtained European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device;
Ashley Young, PhD, Medical Analyst at GlobalData, a leading data and analytics company, offers her view on the implications of this certification:
“Biotronik becoming the first medical device manufacturer to secure MDR certification for a Class III device sets the tone for other companies to follow suit, amidst complaints that the May 2020 deadline set by the EU is too tight.
“The looming deadline to comply with the new MDR guidelines has been putting significant pressure on European medical device manufacturers. There are nearly 500,000 medical devices currently marketed in the EU, all of which will have to be re-assessed under the new regulations to include updated information such as unique device identifiers, post-market surveillance data, safety and clinical performance reports, and more. This represents a huge amount of work for companies in what they are saying is too little time to complete it.
“Biotronik’s MDR certification is a huge milestone. With this certification for such a high-risk device so far ahead of the deadline, Biotronik has shown that it is possible to successfully adhere to the new MDR. GlobalData predicts that the precedent set by Biotronik will strengthen the EU’s position in maintaining their May 2020 deadline, while encouraging other companies to step up their efforts towards compliance.
“Biotronik is a big player in the cardiology device market, which is largely composed of Class III devices. Their now-proven ability to secure MDR certification quickly for high risk devices gives them an advantage over their competitors. Should other companies fail to meet the MDR deadline, GlobalData predicts Biotronik will pull ahead in markets such as Cardiac Rhythm Management, which GlobalData estimates to have been valued at just over $3bn in the EU in 2018 and is still growing steadily.”