Wake-Up Call: Class I Manufacturers, Get an Early Start on EU MDR Compliance

A tardy response will be costly and painful

On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU market must have effectively completed the transition from the previous medical device directive and be fully compliant under EU MDR.

This statement alone may be surprising to certain Class I manufacturers, who assume that their products’ classification as low-risk devices under the previous directive will exempt them from all this EU MDR commotion. These presumptions are misguided because classification requirements listed in the EU MDR are relevant to all manufacturers, irrespective of past classification.

With this deadline in sight, it is crucial that all manufacturers familiarize themselves with these regulatory changes and promptly make a start on implementing necessary measures. Those that fail to achieve compliance on time will be left behind, and their products removed from the market. In light of this industry bustle, this article aims to advise Class I manufacturers about the primary alterations that the EU MDR will enforce, as well as offer practical steps that manufacturers can begin to follow.

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Comments

Notified Bodies

As regular Class I devices do not need Notified Body certification, I presume the lack of NB's will only affect those Class Is, Im and Ir?

Notified Bodies - Response

Yes, indeed, the lack of Notified Body capacity will not directly affect manufacturers of Class I, non-sterile, non-measuring and non-reusable medical devices. Do note, however that these devices must still be compliant to the MDR by the Date of Application, including all the associated post-market obligations, even though there is no external scrutiny.

I might add, that we have at least 2 anecdotal examples of a Class I, non-sterile, non-measuring and non-reusable medical device manufacturers having elements of their Technical Documentation reviewed by their certification body as a part of their Quality Management System assessment. Noting that when an organisation who is otherwise a Notified Body reviews a Quality Management System they are acting only as a certification body!