New EU Medical Device Regulations – What’s the Impact?
OVERVIEW
Partially as a result of the Poly Implant Prothèse breast
implant scandal, where a French manufacturer substituted approved medical-grade
silicone with industrial-grade silicone that ruptured causing a variety of
serious medical implants up to and including death, the European Commission
began developing changes to their Medical Device Directives to prevent this
type of an issue from happening again. The changes resulted in the
drafting of a totally new Medical Device Regulation that was fully released
this past February.
The new EMDR is the most extensive medical device regulation
Europe has seen since the 1990’s. Industry experts are concerned that
regulations will increase costs and eliminate early access to device
innovations that patients in Europe currently experience.
Understanding the contents of this regulation and its
implications is crucial to the effective design, development, marketing, and
utilization of medical devices in the EU.
 |
| European Medical Device Directive |
WHY SHOULD YOU ATTEND
The current Medical Device Regulation stands at 350 pages and is
a complex array of regulations written in the normal legalese. There are
many changes that anyone designing, manufacturing, and/or marketing medical
devices into the EU needs to be aware of when compared to the original Medical
Device Directives. This webinar will detail the changes and discuss their
implications, and provide a greater understanding of the regulation medical
device manufacturers.
AREAS COVERED
At the completion of this webinar participant’s will be able to:
- Explain how the new Medical Device Regulation is
structured
- Define/explain the key sections of the regulation.
- Explain the transition process from the Medical Device
directives to the current Medical Device Regulation
- Define the key differences between the MDD and the new
MDR to include – notified bodies, clinical evidence, pre-market,
transparency and traceability, governance and oversight
- The and descript the changes to regulations from the
Medical Device Directives.
- Define the process and options for conducting the
conformity assessment.
- Explain the expanded role of the notified
body.
- Explain how this new regulation will impact US
companies.
LEARNING OBJECTIVES
Pharma Times Magazine has called the new EU medical device
regulation “A new landscape for medical devices.” The new
regulation has provided manufacturers and regulators alike with a much broader
definition of both medical devices and in vitro diagnostic medical
devices. This much broader definition will contribute to a significant
improvement of medical device products in terms of patient and user safety,
device reliability, and overall quality
WHO WILL BENEFIT
Anyone involved in the design, development, marketing, and
management of medical devices in the European Union. The specific
positions and functions are varied and not restricted to any one function or
job title.
- Audit and Compliance Personnel / Risk Managers
- Research and Development Engineers
- Vice-Presidents, Directors, and Managers of medical
device design functions
- Medical device marketing personnel
For more detail please click on this below link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
Comments
Post a Comment