The European Commission has proposed significant changes to how medical device instructions are provided. A draft regulation seeks to amend Regulation (EU) 2021/2226, potentially expanding the use of electronic instructions for use (e-IFU) to all professional-use medical devices.
The proposal highlights a shift toward greater digitalization in medical device documentation, aiming to simplify access to information for healthcare professionals and streamline regulatory compliance for manufacturers. If adopted, the amendment will enable medical device manufacturers to provide instructions in electronic form for devices used by healthcare professionals, replacing traditional paper forms.
The European Commission is actively seeking feedback on this draft regulation.
The deadline
Medical device manufacturers, EU healthcare providers, and regulatory affairs professionals are invited to review and submit their input by March 21st. The feedback process is designed to ensure balanced consideration of the needs and concerns of all stakeholders.
This regulation, if finalized, is expected to modernize the way critical information is delivered, potentially enhancing accessibility and efficiency across the medical field. The proposed amendments could have far-reaching impacts for manufacturers and healthcare providers, altering long-standing practices related to device documentation.
For those affected by this regulation, now is the time to engage and provide feedback before the March deadline.
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