Draft proposal of the new MDD - Medical Devices Group

Joe Hage

🔥 Find me at MedicalDevicesGroup.net 🔥

July 2016

< 1 min reading time

There is a lot of ado about the approaching changes in the medical device directive, however most of the regulatory professionals do not even know the content of the draft proposals. Here you can download the draft proposals and get credible information from firsthand:

Medical devices: Council getting ready for talks with EP

On 19 June 2015, the Council agreed its negotiating stance on two draft regulations aimed at modernising EU rules on medical devices and in vitro diagnostic devices.

source: https://www.linkedin.com/groups/78665/78665-6155156675331452932

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Posted by Joe Hage

Asked on July 3, 2016 12:00 am

77 views

	Private answer Julie Omohundro Miklos, fascinating comment. What kind of regulatory professionals do you know that are mostly not familiar with the contents of the drafts of the new directives? Are these individuals in the employee of medical device companies, regulatory consulting firms, device law firms, design & development firms, CROs? Marked as spam Report spam
	Private answer Miklo's intresting comment Marked as spam Report spam
	Private answer Yvanne Enever I would like to think that most MD professionals have taken the time to read the drafts that will influence their working practices! Marked as spam Report spam
	Private answer I have consulted with a lot of regulatory affairs managers and CEOs of small and medium-size manufacturers during the last 2 years and my experience was that they rather hope than prepare. This definitely does not hold true for CROs and large companies. Marked as spam Report spam
	Private answer Julie Omohundro Miklos, that sounds about right. I'm surrounded by large CROs, and their regulatory specialists have to stay current to stay competitive. Smaller device manufacturers, it's a different story. They tend to be overloaded and find it hard to keep up. Marked as spam Report spam
	Private answer Has anyone looked into the upcoming UDI requirements, which must be meet by September 2016 Marked as spam Report spam
	Private answer Premkumar Menon Fernando - I am also trying to understand the new UDI requirements can you please suggest some place were i can get more details Marked as spam Report spam
	Private answer For whom maybe interested i suggest this upcoming live webinar that will discuss the following points: -Main New EMDR 2016 Requirements -(UDI) Unique Identification number -Post market activities -New Technical File -Transition from current MDD to new regulation http://mdpharmacourses.com/2016/06/07/medical-device-directive-2016-new-eu-medical-device-regulations-live-webinar/ Marked as spam Report spam
	Private answer UDI's are being used to facilitate location and retrieval of devices (and other items) often within hospitals in the USA. National Recall Alert Center uses this information and others to enable medical facilities in recall alerting, management, tracking, tracing and compliance reporting. Thus using UDI's to close the loop for the standard of care and best practices compliance. Marked as spam Report spam
	Private answer Stacy Livingston premkumar menon if you are planning to attend MEDICA in Dusseldorf this year, Obelis will be holding sessions each day of the show covering each of the facets of the NEW Regulation including UDIs Marked as spam Report spam

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Medical devices: Council getting ready for talks with EP

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