Ongoing Story: Update on Notified Bodies & Certifications Under the EU MDR

Ongoing Story: Update on Notified Bodies & Certifications Under the EU MDR

The European Union (EU) Medical Device Regulation (MDR) comes into force on May 16, 2020, and compliance officers are encountering challenges as the deadline nears. With growing demand for certifications under the new regulation, companies should take immediate steps to populate their technical files with up-to-date substance data.

Companies in scope of the EU MDR will experience a bottleneck as a result of expensive, time-consuming supplier engagement campaigns to satisfy the data requirements, and an alarming lack of notified bodies approved to provide certifications under the new legislation. As a result of these pressures, 73 percent of companies surveyed have accepted the certainty that they won’t be ready to show compliance in time for the deadline.

The European Commission’s target was to establish 20 notified bodies by the end of 2020. This has been complicated by the more stringent qualification criteria applied toward applicants. Currently, seven of 42 applicants have been approved to provide the certification.

Download our guide, “Notified Bodies: Certifying Your Products Under the EU Medical Device Regulation,” for a list of current notified bodies under the new EU MDR.

The results for the EU In-Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) are even more alarming; just two of 10 applicants are approved.

Although companies are noting the difficulty and uncertainty around their new requirements, they’re working toward compliance. In the process, they’re learning reactive due diligence is far more costly than an active supply chain data management strategy.

Waiting to acquire data and certifications results in higher risk of delays in receiving certification and greater long-term costs when implementing risk mitigation measures after the fact. Specifically, failure to manage your new requirements effectively could lead to:

  • Product recalls.
  • Lost market access and void contracts.
  • Reputation damage from adverse media.
  • Damage to human health.
  • Lost access to maintenance and repair substances.

Given the potential impact of a non-compliance event, effective supply chain data management is the best approach to acquiring the data you need for notified body approval and to certify your products for sale.

The Assent Compliance Platform can automate data sendouts and acquire the data you need to populate your technical file. It can also centralize your efforts from the same solution you use to acquire REACH and RoHS data, if necessary.

The Assent blog is your place for updates as more labs are approved to certify the legislation. For more information about how Assent can help medical device companies get ready for their new requirements, contact our experts at