Overview
Distinguish between the MDD Directive and the MDR Regulation to understand the new direct legal enforcement across EU member states., Apply Annex VIII risk-based classification rules, including specific criteria for invasive, active, and software devices (Rule 11)., Define the legal responsibilities of Economic Operators, including Manufacturers, Importers, Distributors, and Authorized Representatives., Construct a Clinical Evaluation Report (CER) that meets strict new evidence standards, moving beyond the "equivalence" route., Validate compliance with General Safety and Performance Requirements (GSPRs) in Annex I, replacing the old Essential Requirements., Understand the 6 modules of EUDAMED
Regulatory Affairs (RA) professionals navigating the transition from MDD to MDR., Quality Assurance (QA) managers responsible for maintaining ISO 13485 and Technical Documentation., Medical Device Manufacturers, Importers, and Distributors needing to understand their specific legal liabilities., Software developers working on HealthTech or SaMD products who need to determine classification.
A basic understanding of the medical device industry or product lifecycles is recommended., Familiarity with Quality Management Systems (ISO 13485) is helpful but not mandatory., No prior legal expertise is required; the course breaks down complex regulations into clear concepts.
“This course contains the use of artificial intelligence.”
The European medical device landscape has undergone its most significant legislative overhaul in decades. The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR 2017/745) is not merely an update; it is a fundamental shift in legal enforcement that demands immediate strategic attention from manufacturers, importers, and distributors globally.
Medical Device Regulations (MDR) Essentials is a professional-grade training program designed to demystify the complex requirements of the new EU framework. This course moves beyond theoretical legal text to provide actionable compliance strategies for maintaining market access in the European Union.
This course is structured to guide professionals through the entire regulatory lifecycle of a medical device. We begin by establishing the legal ground, examining the strict transition timelines and the new "Supply Chain of Trust" liabilities for economic operators. Participants will then navigate the rigorous risk-based classification system (Annex VIII), specifically addressing the up-classification of software (SaMD) and the inclusion of aesthetic products under Annex XVI.
A core focus of this curriculum is the "Proactive Surveillance" paradigm shift. You will learn how to transition from reactive vigilance to proactive Post-Market Surveillance (PMS), ensuring your Technical Documentation (Annex II & III) and Clinical Evaluation Reports (CER) are "living" documents that satisfy Notified Body audits.
Key areas of focus include:
Strategic Transition: Navigating legacy device provisions and the expiration of MDD certificates.
Technical Compliance: Exploring the General Safety and Performance Requirements (GSPRs) that replace the old Essential Requirements.
Clinical Evidence: Understanding strict equivalence rules and the lifecycle approach to Clinical Evaluation (CER) and Post-Market Clinical Follow-up (PMCF).
Transparency & Traceability: Implementing Unique Device Identification (UDI) and understanding EUDAMED.
Designed for regulatory affairs professionals, quality managers, and life sciences executives, this course offers a structured path to understanding the rigorous safety standards required to place—and keep—medical devices on the EU market in 2025 and beyond.
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