The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Miner's MSA (Measurement Systems Analysis) Blog 
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > EU Medical Device Regulations
Forum Username

Wooden Line

Missing expiry date on Class II Medical Device - Recall/Not? What are EU Requirements

Wooden Line
Search the Elsmar Cove
Search Elsmar
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
class ii medical device, european union, european union medical device directives (mdd), expiration date, market recalls, medical devices (general), recall notices, recalls (general)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 23rd June 2011, 05:21 AM
Arnthor

 
 
Posts: 47
Please Help! Missing expiry date on Class II Medical Device - Recall/Not? What are EU Requirements

Hi everyone,

Do I need to conduct a market recall if my manufacturer had failed to print the expiry date of my medical device (class II)?

If yes, what is the recall regulatory requirements in EU?

Please advice

Arnthor

Sponsored Links
  #2  
Old 23rd June 2011, 05:48 AM
sreenu927

 
 
Posts: 506
Re: Missing expiry date on Class II Medical Device - Recall/Not? What are EU Requirem

Hi,

From my view, no need to recall.

You can perform a Field Safety Corrective Action---send a FSN to Competent Authority,NB,EU REP and Customer mentioning the issue. To customer along with FSN, send the updated label or if the units are less, your own field service guyz can go paste the updated label that has expiration date.

And all it depends on the type of this class II product. Is it a reagent/kit/instrument..so based on that, u need to take decision, perform health hazard analysis/risk impact and do field safety corrective action or instruct customers to scrap (provided that you are not confident of the shelf-life validity by this time and it is NOT an instrument).

Follow the MEDDEV 2.12-1 rev 6 Guidelines on Medical device Vigilance System as attached, which requires an Incident reporting for this case.

Regards,
Sreenu
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf 2_12_1-rev_6-12-2009_en[1].pdf (295.8 KB, 32 views)
Sponsored Links

  #3  
Old 23rd June 2011, 06:21 AM
pkost

 
 
Posts: 587
Re: Missing expiry date on Class II Medical Device - Recall/Not? What are EU Requirem

I think it depends on the product and the point of the expiry date. What is the risk to the patient if the product is used after it's use by? Is it possible to determine that the use by has passed without the label? what is the risk of you missing a label even with a FSN?


If the expiry is soon then there is a risk that before you could update the labels a device is used.

I suggest you contact your competent authority and get a definitive answer. Without knowing your product it is not possible to give a good answer. However, in my field with sterile medical implants, I would err towards a recall
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > EU Medical Device Regulations

Do you find this discussion thread helpful and informational?


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
Smilies 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
Expiry Dates on a Non-Sterile Class 1 Medical Device (5 Year Shelf Life). Quality Priest Other Medical Device and Orthopedic Related Topics 5 16th December 2011 08:23 AM
Class I Medical Device Requirements - Annex VII of the Medical Devices Directive welshery EU Medical Device Regulations 6 23rd June 2011 12:32 PM
Class I Medical Device Battery Requirements yodon CE Marking (Conformité Européene) / CB Scheme 1 30th August 2010 03:19 AM
Equipment Cleaning Validation Requirements - Medical Device Class II or Class III RMV09 Other Medical Device and Orthopedic Related Topics 5 25th March 2010 02:26 AM
Discontinuing A Medical Device - Support requirements - Class 2 Medical Device antho10359 ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 2 5th September 2004 03:59 AM



The time now is 03:03 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".