The EU Medical Devices Regulation (MDR) was published on May 5, 2017. The impetus behind these new, more rigorous regulations was in part to reflect the substantial technological and scientific advances made by the medical device sector and in part a response to the need for regulations that would significantly tighten the controls around medical devices. The EU MDR is designed to enable the production of safer, more innovative devices, and it changes not only the responsibilities of manufacturers, but also the role of Notified Bodies.
Recertification of Notified Bodies
One of the main objectives of the EU MDR was to evaluate the existing Notified Bodies and identify which ones were qualified to ensure the safety and effectiveness of the products they were evaluating and certifying and to ensure conformity. In order for Notified Bodies to be able to issue MDR certificates for devices, they need to be recertified according to the new MDR regulations.
Starting on November 26, 2017, Notified Bodies began submitting applications to the relevant Competent Authorities to become designated under the EU MDR. Both BSI and TUV applied for MDR designation in November 2017 and underwent their joint audits by the European Commission in April 2018. In January 2019, BSI became the first Notified Body designated under the EU MDR.
However, reports indicate that 50 percent of EU Notified Bodies have not yet applied for MDR designation, which means that the process is significantly behind schedule in terms of MDR designation and operational readiness from the perspective of Notified Bodies. As such, manufacturers should reach out to their respective Notified Bodies to gain an understanding of where they are in their designation process. In some cases, it may make sense for a manufacturer to leave their existing Notified Body and maintain compliance with another Notified Body. In other cases, a Notified Body may fail recertification under the EU MDR and manufacturers may be confronted with a forced change of Notified Body.
Understanding the review timeline of Notified Bodies
The reality is not all current Notified Bodies will remain in business. Given this state of flux, manufacturers are advised to communicate with their respective Notified Bodies to clarify their intentions and timelines. Questions manufacturers may want to ask with Notified Bodies include:
- How does the Notified Body interpret the EU MDR as it relates to our product portfolio?
- When will the Notified Body be ready to review our technical documentation?
- How long will it take for the Notified Body to complete its review?
Proactive communication with the Notified Body is critical for manufacturers to understand the delays their R&D teams may encounter in bringing a new product to market. With a shrinking number of Notified Bodies, review can take much longer than expected or previously planned for and manufacturers may need to shift their development plans accordingly.
Shifts in the role of Notified Bodies
Under previous Directives, medical devices were not subject to a pre-market authorization by a regulatory authority. Medium- and high-risk devices required a conformity assessment procedure involving a Notified Body. In the new MDR framework, independent experts could be required to provide an opinion to the Notified Body on certified high-risk products before the final decision on certification is made.
While the Notified Body would not be bound by this opinion, it would be required to provide justification for not following it. However, if the expert panel raises concerns about the sufficiency of the level of clinical evidence or the benefit/risk determination of the device, the Notified Body is required to advise the manufacturer to take action to address those concerns.
Under the EU MDR, Notified Bodies will also play a new role in enforcing regulation through unannounced audits of manufacturing processes. These audits may require manufacturers to amend their contracts with subcontractors and/or suppliers.
Understanding the new role of Notified Bodies under the new regulations and communicating proactively with their Notified Body is critical for manufacturers as they transition to EU MDR compliance. Whether it’s establishing timelines for review or clarifying the Notified Body’s interpretation of the EU MDR for a product portfolio, manufacturers benefit from maintaining transparent communications with their Notified Body throughout the device certification process.
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