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Writing for Medical Devices- a European consensus approach

    The requirements for medical writing are witnessing continuous growth influenced in good portion by the mounting government scrutiny and regulatory controls of companies manufacturing and marketing medical devices.

The Regulatory Medical writer needs to possess basic abilities and proper understanding of the critical information about important regulatory checks and must be able to develop and present contents that conform to the regulatory requirements relating to Medical Devices.  The regulatory medical writer’s job is not all about producing and writing contents but also include good project management and presentation skills. The medical device writer must have a complete knowledge regarding safety and efficacy of the medical devices, precision, and validity of measurement devices and sensitivity and specificity aspects while writing about diagnostic equipment. Devices undergo continuous and rapid innovation leading to shorter life-cycle for medical devices. Thus the medical device writers must continually update the subject knowledge and various regulatory guidelines that control the usage of medical devices.

# European Regulatory Guidelines

European Commission for Health and Consumers has established regulatory guidelines for medical devices to be followed by the manufacturers of medical devices and other associated agencies in the marketing of such devices. European regulatory affairs have drafted these guidelines through an intensive consultation with able bodies, commission services, industry agencies and other associated bodies. The European guidelines on medical devices provide comprehensive information relating to the clinical investigation, which is conducted to evaluate the performance and safety standards of the medical device.

European medical devices regulatory document MEDDEV 2.7.1 comprise certain annexure that provides complete details and description of the various regulatory aspects involved in the manufacturing of medical devices.

Important descriptions in the European guidelines on medical device include

  • Nature and objectives of Clinical investigation
  • Scope and Need assessment for clinical investigation
  • General principles clinical investigation plan
  • Ethical considerations for clinical investigation
  • Clinical evidence and Clinical investigation plan
  • Clinical evaluation and safety standards
  • Conformity assessment
  • Endpoint indicators
  • Residual Risk and Risk management policies
  • Relevant legal and regulatory requirements

The European regulatory guidelines on medical devices provide complete explanation of clinical data requirements, study objectives, statistical considerations that can significant influence on the clinical performance, safety, adverse side effects and various risks recognized in the risk management process.

Writing for medical devices should take all these aspects stated in the European Commission guidelines into consideration and ensure developed contents have complete confirmation of these guidelines. Thus, Regulatory writers need to hone the essential skills, gain sufficient regulatory knowledge and experience at every step from medical device prototype development and submission process to excel in the high specialized field of the medical regulatory writing of medical devices.

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Writing for Medical Devices- a European consensus approach


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