The European Medical Device Regulation (MDR) is a new set of regulations that will become effective May 2020. This new set of regulations will replace existing directives of the EU regulatory framework, Medical Devices Directive (MDD) and Active Implantable Medical Devices (AIMD) Directive, to keep up with scientific advances in the medical industry, improve consistency, and increase patient safety. Compliance with the new regulation is mandatory for medical device companies who produce and distribute medical devices in Europe.
Once the EU-MDR is in effect, MRI labeling will be required for all implants to be compliant. All devices that contain any metallic components, such as titanium, (regardless of ferromagnetism) will need to be evaluated and labeled for RF-induced heating, image artifact, and magnetically induced displacement force and torque. The new regulation documents and standards will affect all such devices including those that are already approved and on the market. MRI safety labeling will now be considered a component of responsible risk management for your product. Updating to meet these new standards can be a lengthy process.
At MED Institute, we have helped many US, EU, and other foreign companies evaluate their MRI safety labeling needs. We have considerable experience and expertise in helping device manufacturers update their labeling to meet current standards and regulatory expectations. We can provide an audit of any existing MRI labeling and assess your potential needs to comply with the imminent new regulations. If any additional testing or simulation is necessary, we can perform that as well.
Are you prepared for the impact of the new European Medical Device Regulations (MDR), FDA draft guidance and ASTM draft standards for MRI safety evaluations? Let us help you make a smooth transition into the new regulatory framework.
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