Medical Device Regulations (MDR) Training – 2 Days - Virtual Classroom
June 8 and 9 - 2021
€699 Price includes training, all training materials, certification and refreshments during the training where applicable. Need a quote for In-house Training email us today info@iqc.ie THERE ARE NO HIDDEN FEES AT IQC. Please note that participants attending the MDR course are expected to have prior knowledge of quality management principles and concepts, and the basic requirements of the existing Medical Device Directives. IQC will provide a “Pre-course” pack to all delegates approximately 10 days before the training commences to help you refresh. This MDR Course will soon be available as a Blended Learning option. Curious ? E-mail us today info@iqc.ie.
Introduction
The legislation outlining the requirements for medical device manufacturers prior to placing them on the market in the European Union is changing.
The old Medical Devices Regulation (EU 2017/745) is to be replace the Medical Devices Directive (93/42/EEC). The new regulations place greater emphasis on accountability for all players and with greater scrutiny of both clinical evaluation and post-market clinical evaluations and improved traceability of devices for the full life cycle.
Who should attend this workshop?
This training is aimed at those with a working knowledge QMS from all levels within the organisation including (but not limited to):
• Authorised Representatives
• Manufacturing personnel
• Quality
• Regulatory Affairs
• Design and Development
• Economic Operators for example importers and distributors
Cancellations
Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.
Course Objectives:
The 2 day course on MDR is highly interactive with many team exercises and discussion to give learners a good foundation in the complex and detailed new regulation. Learners will build and enhance their existing knowledge in relation to the new MDR, its implementation and the complexities surrounding the Newly structured Notificed Bodies.
Workshop Summary Day 1
EU-MDR Overview
Quality Management System Changes
Role of Contract Person for Regulatory Compliance (CPRC)
Economic Operators (roles, responsibilities and requirements)
General Safety & Performance Requirements
Material Compliance
Labeling
UDI
Implant Card
IFU
EUDAMED
Workshop – Summary Day 2
Re-Cap Day 1
Classification Reclassification of Products
Non-Medical Products within the SCOPE of the EU MDR
Scrutiny Procedure
Validity of Conformity Assessment, Routes and Certification (Transition Periods)
Clinical Evidence and Evaluation
Post-Market Surveillance
Common Specifications
Content requirements for Technical Documentation
Submission Requirements
Claims