Register to attend the EU MDR Implementation Strategies Virtual Conference | November 6–8, 2019This week Biotronik received the first EU MDR certification for a Class III medical device. The certification has significant implications and is a “huge milestone”, because it proves that companies can successfully comply with MDR, according to Ashley Young, Ph.D., a medical analyst at GlobalData. She adds that this certification will only make the European Union even firmer in keeping the May 2020 deadline.
“The looming deadline to comply with the new MDR guidelines has been putting significant pressure on European medical device manufacturers,” said Young in a GlobalData news release. “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.”
Young added that Biotronik’s ability to receive MDR certification ahead of other companies will serve as a competitive advantage, and will help the company accelerate its position in the cardiac rhythm management market.