The European Union’s Medical Device Regulation will affect your medical products and their Instructions for Use (IFUs).
In 2008, an effort was started to overhaul the medical device directive. This was due to several high-profile medical device scandals and increasing public concern to strengthen the existing CE regulatory system. In 2017, the MDR directive (2017/745) was published to address these issues and bolster confidence in the EU medical device regulation system.
The EU MDR will replace the current AIMDD (Active Implantable Medical Device Directive) and MDD (Medical Device Directive) and by May 26, 2020 all medical device manufacturers will need to be compliant.
Ensure you have all the information necessary to conduct a current-state analysis and pinpoint the areas that need to be addressed according to new regulatory requirements in the EU MDR directive.
Key Takeaways:
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Learn how IFUs and patient manuals will be affected by EU MDR.
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Understand the implications of MDR on CE market products.
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Identify the language gaps for distributing products in the European Union.
