The Cove Business Standards Discussion Forums
EU MDR and PSUR (Periodic Safety Update Report)
Please read this thread...
Software update
EU MDR and PSUR (Periodic Safety Update Report)
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

EU MDR and PSUR (Periodic Safety Update Report) - Page 2

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
mdr (medical device regulations), psur (periodic safety update report)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #9  
Old 18th July 2018, 01:41 PM
GLM12345

 
 
Total Posts: 1
Re: EU MDR and PSUR (Periodic Safety Update Report)

There is a template for the PSUR, which is nice because takes the guessing out of how this this thing should look. I cannot figure out how to post a thread here, need to figure that out. My question is given the scope of the new EU MDR, why would a PMS PLan be required for a device that is not even sold/marketed in the Union? EU is concerned about devices in their jurisdiction, versus a China only product, what good is a PM PLan for that if its not even distributed in EU?


Sponsored Links
  Post Number #10  
Old 19th July 2018, 09:41 AM
14cross

 
 
Total Posts: 2
Re: EU MDR and PSUR (Periodic Safety Update Report)

Can you provide a link to this template you reference? I have searched and only find templates for drugs, not medical devices.
  Post Number #11  
Old 19th July 2018, 10:07 AM
Wolf.K

 
 
Total Posts: 72
Re: EU MDR and PSUR (Periodic Safety Update Report)

Probably first EUDAMED will go online before we can upload PSURs. Therefore, I think currently we still do not need PSURs.
  Post Number #12  
Old 9th August 2018, 08:26 AM
Berni

 
 
Total Posts: 2
Re: EU MDR and PSUR (Periodic Safety Update Report)

Quote:
In Reply to Parent Post by GLM12345 View Post

There is a template for the PSUR, which is nice because takes the guessing out of how this this thing should look. I cannot figure out how to post a thread here, need to figure that out. My question is given the scope of the new EU MDR, why would a PMS PLan be required for a device that is not even sold/marketed in the Union? EU is concerned about devices in their jurisdiction, versus a China only product, what good is a PM PLan for that if its not even distributed in EU?


I hope you can share it. I'm preparing the plan for MDR transition and PSUR is totally unknown for me.
  Post Number #13  
Old 9th August 2018, 09:35 AM
FoGia

 
 
Total Posts: 44
Re: EU MDR and PSUR (Periodic Safety Update Report)

Quote:
In Reply to Parent Post by Berni View Post

I hope you can share it. I'm preparing the plan for MDR transition and PSUR is totally unknown for me.

There is no template currently for PSUR in the frame of the MDR. I guess you are referring to the guideline from the European Medicines Agency (which is not applicable to medical devices): http://www.ema.europa.eu/docs/en_GB/...C500142468.pdf
  Post Number #14  
Old 9th August 2018, 09:48 AM
FoGia

 
 
Total Posts: 44
Re: EU MDR and PSUR (Periodic Safety Update Report)

Quote:
In Reply to Parent Post by Wolf.K View Post

Probably first EUDAMED will go online before we can upload PSURs. Therefore, I think currently we still do not need PSURs.

From what I've heard PSURs will need to be submitted - even via e-mail if it needs to be - even if Eudamed will not be ready, and they will be required to be on file as from November 2020 (for all devices).
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Safety Assurance Case Report for a Medical Device WAF64 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1 25th May 2011 03:50 AM
Safety Audit Report example and explaination wanted Tiffany Other ISO and International Standards and European Regulations 3 19th May 2010 12:20 PM
Safety Hazard Analysis Report - Need format or an example al40 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6 16th May 2007 12:59 PM
Server Software Update - 2 Dec 2006 - Possible issues - Please report problems here Marc Old Forum News and Issues Threads Archive 16 3rd December 2006 12:00 AM
Bug Report Thread - Software update - 040416 Marc Old Forum News and Issues Threads Archive 13 28th April 2004 09:17 PM



The time now is 11:09 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"