Medical Device Regulation (EU) 2012: MDR 2017/745 Compliance Training

TERMINAL OBJECTIVES

After this presentation, participants are expected to become:

1. By the end of the training, trainees should be capable of contributing effectively to their organization’s compliance strategy for MDR 2017/745.
2. Ensuring the successful launch and maintenance of medical devices in EU Market.

SESSION OBJECTIVES

At the end of the presentation participants should be able to do the following:

1) Understanding the Regulatory Framework

1. Gain a comprehensive understanding of the MDR 2017/745 regulatory framework and its requirements.
2. Learn about the scope, objectives, and significance of MDR in ensuring medical device safety and performance within the European Union.

2) Risk Classification and Device Conformity

1. Understand the classification of medical devices (Class I, IIa, IIb, III) and how it impacts regulatory requirements.
2. Learn how to determine the appropriate conformity assessment routes based on device classification.

3) Technical Documentation and CE Marking

1. Understand the requirements for preparing and maintaining technical documentation under MDR.
2. Learn the process for obtaining CE marking and the associated requirements.

4) Clinical Evaluation and Post-Market Surveillance (PMS)

1. Understand the importance of clinical evaluation, performance studies, and evidence generation under MDR.
2. Learn how to implement and manage robust Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) systems.

5) Roles and Responsibilities of Economic Operators

1. Understand the roles and responsibilities of key stakeholders, including manufacturers, authorized representatives, importers, and distributors.

6) Risk Management and Usability Engineering

1. Learn the principles of risk management (ISO 14971) and usability engineering to ensure device safety and effectiveness.

7) Quality Management Systems (QMS)

1. Gain insight into establishing and maintaining a QMS aligned with ISO 13485 and MDR requirements.

8) Notified Body Interactions

1. Learn how to prepare for and manage interactions with Notified Bodies for conformity assessments.

9) Transition from MDD to MDR

1. Understand the key differences between MDD (Medical Device Directive) and MDR.
2. Learn the steps required to transition existing devices and processes to comply with MDR.

10) Audit Preparation and Compliance

1. Develop skills to prepare for regulatory audits and inspections under MDR.
2. Gain knowledge about compliance with MDR reporting and vigilance requirements.

11) Ethical and Social Responsibilities

1. Understand the ethical requirements, including transparency in labeling, traceability, and the role of Unique Device Identification (UDI).

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