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Basics of Writing for Medical Devices under the MEDEV rev. 4 and new Medical Devices Regulations

Level:
Foundation
Area:
Medical Devices
Code:
MDF1
Duration:
03:30:00
Workshop profile:
Medical writers with experience in medical communications or regulatory writing. Some experience and understanding of the regulatory requirements for the market approval of medicinal products is expected.
Objective:
To introduce the field of medical devices and associated document requirements. Areas covered include: classification of medical devices, basic regulatory issues regarding the approval and marketing of medical devices, recent changes in regulatory requirements and how these impact the medical writer’s role, as well as some of the most common medical communication documents.
Content:
A syringe, a knee prosthesis, a computerised tomography (CT) scanner, an external defibrillator, and a pacemaker are all medical devices, but they belong to different risk classes. The new regulations (MEDEV rev. 4 and Medical Device Regulation) define a core documentation set required for regulatory compliance of these devices. And this can be challenging for the industry and the medical writer. Focusing on a set of different medical devices, the main elements of the workshop will introduce: • What is a medical device and why and how they are classified • Key documentation for regulatory compliance and market release of a medical device • Medical communication texts: particularities for medical devices The workshop will include group exercises and discussions as well as evaluations of real documents.