The Cove Business Standards Discussion Forums
MDD in 2018 - Company with no previous EU approval
UL - Underwriters Laboratories - Health Sciences
MDD in 2018 - Company with no previous EU approval
MDD in 2018 - Company with no previous EU approval
MDD in 2018 - Company with no previous EU approval
MDD in 2018 - Company with no previous EU approval
MDD in 2018 - Company with no previous EU approval
MDD in 2018 - Company with no previous EU approval
MDD in 2018 - Company with no previous EU approval
MDD in 2018 - Company with no previous EU approval
MDD in 2018 - Company with no previous EU approval
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

MDD in 2018 - Company with no previous EU approval


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

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
2018, mdd (medical device directive)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 1st May 2018, 11:25 AM
snoopy2017

 
 
Total Posts: 86
Question MDD in 2018 - Company with no previous EU approval

For a company that is seeking approval in the EU for the first time (e.g. no MDD certificates but going straight to the MDR), is it still worth going for the MDD certificates right now? Otherwise, this company will have to wait until mid 2019 to receive approval. They would like to get into the EU market as soon as possible. Are there companies still certifying to the MDD in 2018? if so, what would be the transition timeline for them?

Sponsored Links
  Post Number #2  
Old 2nd May 2018, 04:33 AM
FoGia

 
 
Total Posts: 28
Re: MDD in 2018 - Company with no previous EU approval

The MDD certificates will still be valid under MDR (until they expire), so in theory you can market the product until 2024-2025 but there are a few constraints that apply, the most important one being that there must be no significant changes in the design and intended purpose of the device and that the manufacturer can't change of notified body, so you better make sure that the NB will still be around (not all NB have applied for designation under MDR). Post-market surveillance under MDR for these devices is the same as for devices cleared in the frame of the MDR.
Another practical consideration relates to the NB's workload, 2018 should still be achievable but NBs will be working full steam on MDR filings from summer 2019 onward, that won't leave much room for MDD filings.
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
ISO 9004:2018 Revision - Released April 2018 thenson ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9 19th April 2018 08:33 AM
Document Approval Process for Company Documents tfanderson Document Control Systems, Procedures, Forms and Templates 20 26th January 2012 08:58 AM
ISO 9001 Quality Manual - Is it OK for me to use content from my previous company? Mike H. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13 29th November 2011 09:13 AM
Peanut Product Recall Took Company Approval Marc Food Safety - ISO 22000, HACCP (21 CFR 120) 8 3rd February 2009 09:04 PM
Supplier Evaluation and Approval of a Translation company medic61 ISO 13485:2016 - Medical Device Quality Management Systems 6 2nd February 2009 05:32 PM



The time now is 07:07 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"