Download the AssurX "EU MDR and IVDR Timeline" Infographic

What should companies be doing now to prepare?

The first steps for medical device compliance are understanding which devices need to be certified (or re-certified) by May 26, 2021. From there, companies need to get ready for certification audits by notified bodies (NBs), which includes adding new staff for non-EU companies, updating the QMS, and preparing documentation.

Let’s look at some of the details around these action items, and what’s next on the horizon in terms of MDR timelines.

Submit your information and download the AssurX EU MDR and IVDR Timeline infographic today!

More resources.

EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution

This webinar shares strategies for efficiently managing postmarket challenges faced by medical device manufacturers marketing devices in the EU.

Download the AssurX EU MDR Clinical Data Checklist eBrief

This eBrief provides a brief list of items to consider before embarking on a design change to a medical device planned for distribution to one of the European Union member states.

Questions? Please contact us at [email protected].

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