Many companies in the industry have been preparing for the In Vitro Diagnostic Regulation (IVDR) rollout since it was announced in 2017. As the application date quickly approaches, manufacturers need to be aware of and plan for when the new regulations take effect.

One of the first steps in beginning the transition is determining if the product(s) fall within the scope of the regulation. For instance, research use only, general laboratory use, and veterinary use products are not within the scope of the IVD Regulation. When classifying software paired with a medical device, specific considerations could be made more challenging to determine the classification.

 As with other regulatory bodies, the classification under IVDR is dependent mainly on the products intended for use. If a product has more than one intended use, the highest class applies to the product.

Under the new regulation, there is much more extensive involvement of notified bodies, with an estimated 80% of products under the law requiring notified body assessment[i]. This increase in notified body involvement may become an issue as the IVD regulatory system is already constrained due to the pandemic and will be further constrained since the number of designated notified bodies has further been reduced under the new regulation.

One of the most critical updates in the transition to IVDR is focusing on the manufacturer’s quality management system (QMS). The new regulations state that all IVD manufacturers must have a QMS, regardless of their device classification. While most QMS requirements fall within the ISO 13485:2016 standard, post-market surveillance is also needed.

The new surveillance (PMS) regulations require manufacturers to establish a system and develop a plan to guide that system. The new rules need the manufacturers to proactively approach PMS and create documentation such as periodic safety update reports (PSURs).

The introduction of more stringent regulations for IVD devices solidifies the need for manufacturers to understand how to be compliant. The transition from IVDD to IVDR can be difficult between new classifications and new rules. EMMA International experts can help guarantee products are compliant with all new regulations and ensure the application deadline is met. For more information, contact EMMA International by phone at 248-987-4497 or email at info@emmainternational.com.


[i] https://www.nsf.org/knowledge-library/most-common-ivdr-challenges


Emma International

Emma International

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