The European Medical Device New Regulation 2017/745
This 11-part course covers all aspects of the EU MDR 2017/745 in a comprehensive manner, providing practical guidance and identifying major differences with the current MDD/AIMD on the following topics:
- Basics and background of EU medical device regulations, including roles and responsibilities of key players (such as notified bodies and competent authorities)
- Structure of the EU MDR and other related regulations
- Definition and classification of medical devices (MEDDEV 2.4/1 Rev 9)
- Conformity assessment procedures and routes
- Quality system requirements
- General safety and performance requirements in Annex I and the use of harmonized standards
- Clinical evaluations, including references to MEDDEV 2.7.1/Rev 4 and clinical investigations
- Technical file and design dossier requirements
- Medical device vigilance
- Designation and oversight of notified bodies by the Medical Device Coordination Group
- UDI-DI requirements in Annex VI (to be released in Q1 2020)
Upon completion of this course, learners will have acquired:
- A good understanding of the European regulatory model according to the MDR 2017/745 and know how to apply the key principles.
- Know how to use related product specific directives in conjunction with the MDR
- Understand the combination products requirements and how to apply interactions with the directive for medicinal products, tissue of animal origin products and others as per demarcation guidance.
- Make decisions on what clinical data are needed for CE-mark and how to safely keep the product on the market in compliance with the post market surveillance requirements of the MDR and related guidance documents
- Apply the requirements for technical file and design dossier
- Understand how Notified Bodies are designated and what their interactions are with MDCG and expert groups
- Apply the UDI-DI requirements outlined in Annex VI
Regulatory Affairs Associates and Managers; Quality Assurance Associates, Managers, and Engineers; Manufacturing Engineers; Supply and Purchasing Managers; Design and Validation Engineers; Notified Body, Internal, and Lead Auditors; Regulators; Electrical Safety Engineers; Pre-Clinical Study Managers; Clinical Affairs Directors; Clinical Project Managers; Export Managers; and R&D Engineers are welcome to participate in this course.
Knowledge of basic regulatory principles outlined in the GHTF documents is encouraged. The course does, however, cover MDR basic principles.