Course Name
Medical Device Regulation (EU) 2012: MDR 2017/745 Compliance Training
Course Overview
Welcome to the Medical Device Regulation (EU) 2012: MDR 2017/745 Compliance Training provided by ARG Academy. This comprehensive program is designed to help organizations navigate the European Union’s regulatory landscape and understand the key differences between the previous Medical Device Directive (MDD) and the current MDR. The curriculum is structured systematically, with Day 1 focusing on the regulatory framework, economic operators, and QMS, followed by Day 2 which serves as a masterclass on risk classification, technical documentation, and clinical evaluation.
Course Objective
By the end of this training, participants will be able to achieve the following session objectives:
● Gain a comprehensive understanding of the MDR 2017/745 regulatory framework, including its scope, objectives, and role in ensuring device safety within the EU.
● Understand device risk classifications (Class I, IIa, IIb, III) and determine the appropriate conformity assessment routes.
● Learn the requirements for preparing technical documentation and obtaining CE marking.
● Understand the importance of clinical evaluation, evidence generation, and managing robust Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) systems.
● Identify the roles and responsibilities of economic operators, including manufacturers, authorized representatives, importers, and distributors.
● Learn principles of risk management (ISO 14971), usability engineering, and how to align a QMS with ISO 13485 and MDR requirements.
● Prepare for interactions with Notified Bodies, regulatory audits, and understand ethical requirements like traceability and Unique Device Identification (UDI).
Course Benefits
Participating in this compliance training provides critical advantages for both professionals and their organizations:
● Trainees will become capable of contributing effectively to their organization’s overall compliance strategy for MDR 2017/745.
● The training ensures the successful launch and ongoing maintenance of medical devices within the EU Market.
● Participants will learn the exact steps required to transition existing devices and processes to comply fully with the new MDR standards.
Who Must Attend
Based on the course objectives, this training is essential for:
● Key economic operators targeting the EU market, including manufacturers, authorized representatives, importers, and distributors.
● Quality and regulatory professionals responsible for establishing QMS aligned with ISO 13485, technical documentation, and CE marking.
● Personnel involved in risk management (ISO 14971), clinical evaluation, performance studies, and post-market surveillance.
● Staff tasked with managing regulatory audits, inspections, vigilance reporting, and interactions with Notified Bodies.
Methodology
The course utilizes an interactive lesson plan designed to facilitate practical understanding:
● Facilitator-Led Instruction: Trainers will illustrate overviews of complex topics (like the regulatory framework, clinical evaluation, and risk classification) using PowerPoint presentations, flip charts, and handouts.
● Active Engagement: The program starts with a 30-minute ice-breaker asking participants to elaborate on the question, “What is Medical Device Regulation (EU) 2012-2017/745?”.
● Participant Practice: Attendees will actively participate by writing down what they know about the regulatory framework, answering provided questionnaires, and engaging in Q&A sessions.
● Structured Wrap-Up: The course concludes with a 5-minute summary review of the entire presentation and a 2-minute knowledge transfer session to distribute MDR training materials and ISO/EN guidelines.
Course Duration
● The core curriculum of this training is delivered over Day 1 and Day 2.
● The daily schedule incorporates specific time allocations for structured learning, including a 30-minute introduction, a 5-minute summary review, and 2 minutes for transferring reference guidelines.
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