Elsmar Cove Quality DiscussionsRisk Management for Drug-Device CombinationsThe Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
Risk Management for Drug-Device Combinations
UL - Underwriters Laboratories - Health Sciences
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Risk Management for Drug-Device Combinations
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Risk Management for Drug-Device Combinations


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




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

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
ce mark and ce marking, combination devices and related rules, combination drug-device products, post market surveillance, risk management and analysis
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 20th April 2015, 08:14 AM
Dollymixture

 
 
Total Posts: 3
Please Help! Risk Management for Drug-Device Combinations

I have a question regarding the European MDD requirements for drug-device combination products - specifically a pre-filled syringe.
I know that this type of combination product is approved via the EU medicinal legislation, in conjunction with satisfying the ERs of the MDD for the device element.

My question is specifically in relation to how to manage post-market risk management/post market surveillance in accordance with ISO 14971 and ISO 13485 for the device part.

In the post market phase, the drug-device combination will be subject to the medicinal pharmacovigilance requirements.
Does the medical device vigilance requirements apply to the device element?

Can anyone tell me how they manage the device post market surveillance requirements & post-production monitoring risk management processes for this type of product?

In practical terms, do you end up with a parallell post market process for the device portion and the medicinal/combination portion of the product?

Any advice or practical help would be very much appreciated!

Sponsored Links
  Post Number #2  
Old 19th February 2018, 06:19 PM
TorstenKn

 
 
Total Posts: 1
Re: Risk Management for Drug-Device Combinations

Even though this is an old post and the last request to answer is already six months old, I will try to explain.

First of all, there are two things which need to be differentiated:

1. Risk Management requirement
2. Vigilance requirements

Concerning the vigilance, I have to say that there is no requirement in Europe to report Incidents related to such a single-entity product (e.g., pre-filled syringe) under Device reporting. As such a pre-filled syringe is approved under the medicinal product directive, any issues need to be reported under drug reporting.

Actually in Japan (since November 2016) and in the US (as of Mid of 2018) it is different. In those countries, you have to decide if a reportable case is caused by the drug or device part and then you have to report either under device or drug reporting or even both reporting pathways.

When it comes to Risk Management for a single-entity in Europe, as the question author already said, there is the requirement to comply with the Essential Requirements. This means you have to consider Risk Management for the device, respectively the combination product. Therefore you have to set up and maintain a risk management file.
Thanks to TorstenKn for your informative Post and/or Attachment!
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
What ever happened to Medical Device Risk Management, anyway? Julie O 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17 30th November 2016 11:03 PM
ISO 14971 Medical Device Risk Management FAQ Marcelo Antunes ISO 14971 - Medical Device Risk Management 33 22nd January 2015 04:12 AM
Medical Device Risk Management Plan Tiffany ISO 14971 - Medical Device Risk Management 11 8th November 2011 12:21 PM
Draft FDA Guidance on "Presenting Risk Information in Prescription Drug and Device" yana prus US Food and Drug Administration (FDA) 1 11th August 2009 08:34 AM
Drug Device combinations - Drug degradation and impurities Brig67 Other Medical Device and Orthopedic Related Topics 2 20th March 2009 01:11 PM



The time now is 08:19 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"