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Navigating EU MDR compliance: Overcoming challenges to sustain your certification

Hilde Viroux Maggie Chan

By Hilde Viroux, Maggie Chan

Med Device Online

19 March 2024

PA Consulting medtech expert Hilde Viroux and PA life sciences expert Maggie Chan co-authored a series on EU MDR Compliance for Med Device Online with Dona O’Neil from Northeastern University. Click here to read their first article on how manufacturers of medical devices can overcome certification challenges.

Since the introduction of the EU MDR in 2017, the medical device industry has learned just how challenging obtaining initial MDR certification truly is. According to a survey of notified bodies, the number of certificates issued as of June 2023 covers roughly one-third of the applications submitted. Taking into account that it can take months to have an application approved, and then six months to two years before the certificates are issued, it is no surprise that there is a lot of fatigue with EU MDR in general. The requirements keep being updated, timelines extended, and the EU database for medical devices, EUDAMED, is still not up and running. Notified bodies are also struggling to keep up with the demand for reviews of MDR certificates, consequently impacting the ability to accurately predict certificate approval timeline and budget.

Click here to read the full article on Med Device Online

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