Medical Device Regulations (MDR) Training
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 replaced by 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 postmarket clinical evaluations and improved traceability of devices for the full life cycle.
Who should attend:
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
• Regulatory Affairs
• Design and Development
• Economic Operators for example importers and distributors Course
The 1-day course on MDR is highly interactive with many team exercises and discussion.
Some of the specific topics covered include the following:
Device and product families MDR implications
Introduction to MDR Manufacturers Article
Classification Documentation Changes
Conforming with MDR UDI
Clinical Investigations Vigilance and PSUR/PMS
Safety Performance Labelling
Authorised Representative MDR Audits and Inspection readiness
Eudamed and MDGC Distribution
MDR and other Certifications / Regulations
Vigilance and PSUR/PMS
MDR Audits and Inspection readiness
Delegate cancellation policy
Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.
Photography at events
There may be a photographer and videographer at the event and we may publish images from this event on our website(s) and on our social media accounts.