The IVD regulation is significantly more demanding than its predecessor, the IVD Directive. Economic operators, in particular IVD manufacturers, are facing challenges not just to carry out the necessary remediation activities, but also to firstly identify those requirements that apply to their devices, and to develop a sufficiently robust strategy to tackle the demands of the IVDR and the impact that the regulation will have on their company.

 

For the first time, many manufacturers are faced with notified body involvement in the CE marking of their devices – 80% of devices under IVDR will be under notified body control, compared to just 8% under the Directive. This transition is placing a huge burden on manufacturers and notified bodies alike.

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What are the timelines? 

In an effort to compensate for the limited notified body capacity, the class D device deadline has been extended to 2025. Class C devices must be in compliance by 2026, and class B and class A sterile devices must comply by 2027. While some manufacturers have benefited from the extended timelines, as of May 2022 all non-sterile class A devices must be CE marked under IVDR, and post-market surveillance activities for all devices are also applicable from this date.

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Make sense of the IVDR 

To help you understand where you are at in your IVDR journey, this FREE essential checklist will allow you to make a determination on how far you’ve come in your IVDR journey, and the volume of work that remains outstanding.

 

This checklist will help you to answer the following questions:

• Will our IVD classification and conformity assessment route change under the IVDR?

• Does our current QMS meet IVDR requirements?

• Have we identified and appointed all necessary economic operators, and put in place any applicable agreements?

• Does our current technical documentation meet IVDR requirements, and if not, what do we need to do to rectify this?

• Do we have enough resources in place to rectify any shortfall?

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