European Union Device Regulation (eu Mdr)

By Author: Netzealous LLC,DBA -Compliance4all
Total Articles: 13
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European Union Device Regulation (EU MDR)
The new European Union Device Regulation (EU MDR), which will become effective in May 2020, introduces the most far-reaching changes into the medical device industry in the European Union (EU) till now. Replacing the earlier MDD, the EU MDR drastically expands the requirements for conformance.
It is a massive document that is spread over 174 pages, nearly three times the size of the MDD. It is replete with 123 Articles in 10 Chapters and 17 Annexes. Despite its already heavy size, it is still incorporating new requirements and expanding existing ones. Its fast approaching deadline is leaving medical device manufacturers limited time to prepare.
It goes without saying that products destined for import into the EU must comply with these new regulations. Among the prime requirements that a medical device company has to undertake is an arrangement to be made with a Notified Body, an Authorized Representative and a Person Responsible for Regulatory Compliance. All of these call for extensive preparation.
Not doing this rightly has its consequences. A valuable webinar ...
... from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will explain what needs to be done to meet the deadline, so that the unpleasant consequences of noncompliance can be avoided.
For this webinar, Compliance4All brings Edwin Waldbusser, who has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past eight years, as the expert.
Please log on to Compliance4all to register for this very important learning.
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The core objective of this webinar is to explain and clarify these new and expanded requirements. In the course of doing this, Edwin will cover these areas of all the aspects of the new MDR at this session:
• EU MDR objectives
• QMS requirements
• Device classification changes
• Documentation requirements
• Clinical evaluation requirements
• UDI and labelling requirements
• Post market surveillance
• New Notified Body obligations
• Human Factors/Usability requirements
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About the speaker: A Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network; Edwin Waldbusser is a consultant who has retired from industry after 20 years in management of development of medical devices. He holds five patents.