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
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

Elsmar Cove Forum Visitor Notice(s)


Search the Elsmar Cove
Custom Search
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
Sponsor Links





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
belgium, ce mark and ce marking, class i medical device, class ii medical device, european union, france, germany, italy, medical devices (general)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 24th November 2010, 09:28 AM
RAspecialist RAspecialist is offline
Getting Involved (6 to 9 Posts)

 
Registration Date: May 2010
Location: UK
 
Posts: 9
Thanks Given to Others: 0
Thanked 0 Times in 0 Posts
Karma Power: 18
Karma: 10
RAspecialist has less than 100 Karma points so far.
Please Help! EU Country Specific Medical Device Registration Requirements

HI

We have both Class I and Class IIb medical devices which are CE marked. We would like to launch into:
  • Germany
  • Belgium
  • Italy
  • France
I am therefore wondering what the country specific registration/ notification procedures are in order to sell into those markets?

I have met all the translation requirements.

Can anyone help?

Thank you

Sponsored Links
  #2  
Old 24th November 2010, 11:19 AM
SteveK's Avatar
SteveK SteveK is offline
Appreciated Information Resource

 
Registration Date: Nov 2007
Location: Manchester, UK
Age: 60
 
Posts: 639
Thanks Given to Others: 148
Thanked 684 Times in 311 Posts
Karma Power: 98
Karma: 3671
SteveK is appreciated, and has over 1700 Karma points.
SteveK is appreciated, and has over 1700 Karma points.SteveK is appreciated, and has over 1700 Karma points.SteveK is appreciated, and has over 1700 Karma points.SteveK is appreciated, and has over 1700 Karma points.SteveK is appreciated, and has over 1700 Karma points.SteveK is appreciated, and has over 1700 Karma points.
Lurker Re: EU Country Specific Medical Device Registration Requirements

Strictly speaking, if you have registered the Class I devices with the MHRA (self certification) and your Class IIb devices though your notified body – that should be it for the EU market. CE marking should allow free movement throughout the EU i.e. from article 14 of MDD:

Any manufacturer who, under his own name, places devices on the market in accordance with the procedures referred to in Article 11 (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned.

However, the Italians have put in an extra layer in the process see thread:

Italian Ministry of Health Medical Device Databank regulation

Steve
Thanks to SteveK for your informative Post and/or Attachment!
Sponsored Links

  #3  
Old 24th November 2010, 12:04 PM
bio_subbu's Avatar
bio_subbu bio_subbu is offline
S. Subramanian

 
Registration Date: Aug 2007
Location: India
 
Posts: 594
Thanks Given to Others: 220
Thanked 920 Times in 375 Posts
Karma Power: 98
Karma: 5385
bio_subbu is appreciated, and has over 1700 Karma points.
bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.
Send a message via Skype™ to bio_subbu
Re: EU Country Specific Medical Device Registration Requirements

Quote:
In Reply to Parent Post by RAspecialist View Post

HI

We have both Class I and Class IIb medical devices which are CE marked. We would like to launch into:
  • Germany
  • Belgium
  • Italy
  • France
I am therefore wondering what the country specific registration/ notification procedures are in order to sell into those markets?

I have met all the translation requirements.

Can anyone help?

Thank you
You may want to contact the competent authority of the each member state where the product is marketed (eg, Germany, Belgium, Italy, France). Normally, the product registration can be done through manufacturers with registered office in member states or authorized representative or distributors. A list of contact points (PDF version) for medical devices national competent authorities can be found here.
  #4  
Old 24th November 2010, 12:53 PM
MIREGMGR MIREGMGR is offline
Appreciated Information Resource

 
Registration Date: Aug 2008
Location: SE Michigan, USA
 
Posts: 3,354
Thanks Given to Others: 1,161
Thanked 2,499 Times in 1,532 Posts
Karma Power: 414
Karma: 27446
MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.
MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.
Re: EU Country Specific Medical Device Registration Requirements

Quote:
In Reply to Parent Post by bio_subbu View Post

You may want to contact the competent authority of the each member state where the product is marketed (eg, Germany, Belgium, Italy, France).
As SteveK notes above, this is neither necessary nor desirable except for the Italy situation.
  #5  
Old 6th May 2011, 07:11 AM
Burgmeister Burgmeister is offline
Involved in Discussions

 
Registration Date: Jul 2009
Location: UK
 
Posts: 102
Thanks Given to Others: 45
Thanked 19 Times in 15 Posts
Karma Power: 31
Karma: 108
Burgmeister is appreciated, and has over 100 Karma points.Burgmeister is appreciated, and has over 100 Karma points.
Re: EU Country Specific Medical Device Registration Requirements

Quote:
In Reply to Parent Post by MIREGMGR View Post

As SteveK notes above, this is neither necessary nor desirable except for the Italy situation.
Sorry, for my slowness here, but are you saying that if your (in our case Class IIb) device is CE marked in the UK, you do not need to register at all with the French authorities before marketing there? I know that the EU is supposed to offer free trade and movement of goods, but in addition to the Italian situation, I know that registration is required in Portugal and Spain which makes a bit of a mockery of the whole thing ( I appreciate that the OP made no mention of Spain and Portugal but I was using them as examples of where registration is required in the EU).

Thanks
Thanks to Burgmeister for your informative Post and/or Attachment!
  #6  
Old 6th May 2011, 07:50 AM
pkost pkost is offline
Appreciated Information Resource

 
Registration Date: Oct 2007
Location: UK
 
Posts: 576
Thanks Given to Others: 99
Thanked 415 Times in 271 Posts
Karma Power: 89
Karma: 2369
pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.pkost is appreciated, and has over 1700 Karma points.
Re: EU Country Specific Medical Device Registration Requirements

As previously stated, there is no need to notify any of the CA's if you have already gained a CE mark through your local NB (in case of class II) and your local CA (MHRA) (in the case of class I). Italy is the only exception as they require registration of all devices to sell into their healthcare system.

We sell into Spain and have not had to register there either - what do you mean by having to register for spain and portugal?
  #7  
Old 6th May 2011, 08:06 AM
Burgmeister Burgmeister is offline
Involved in Discussions

 
Registration Date: Jul 2009
Location: UK
 
Posts: 102
Thanks Given to Others: 45
Thanked 19 Times in 15 Posts
Karma Power: 31
Karma: 108
Burgmeister is appreciated, and has over 100 Karma points.Burgmeister is appreciated, and has over 100 Karma points.
Re: EU Country Specific Medical Device Registration Requirements

Quote:
In Reply to Parent Post by pkost View Post

As previously stated, there is no need to notify any of the CA's if you have already gained a CE mark through your local NB (in case of class II) and your local CA (MHRA) (in the case of class I). Italy is the only exception as they require registration of all devices to sell into their healthcare system.

We sell into Spain and have not had to register there either - what do you mean by having to register for spain and portugal?
OK, may have been mistaken about Portugal, but I'm not certain. For Spain, however, we definitely had to provide a CE certificate and list of products we wished to market. This was done through our Spanish distributor so not sure of the exact address to which this was sent or whether she filled in any other 'registration form'.

Edit: I have just looked out the email from our Spanish Distributors and this was their requirement:

In order to register your products with the Health Authorities, could you please be so kind to send me as soon as possible the following information?:

1. GMDN (Global Medical Device Nomenclature) of all the products.
2. Latex Free Certificate.
3. Product classification (Whether the product belongs to Class III, IIb, IIa or I), including all instrumentation.
4. Labels with the CE Mark, from the unit packaging and the protective packaging (Implants and instruments).
5. Insert or instruction manual (IFU) with the CE Mark.
6. If the product belongs to class III, the design certificate should also be included.
7. Declaration of Conformity for the Implants and the Instruments (With a complete list of all the references and descriptions).
8. EC Certificate.
9. ISO Certificate.

Thanking in advance your assistance.

Last edited by Burgmeister; 6th May 2011 at 08:50 AM. Reason: Additional info
  #8  
Old 6th May 2011, 10:52 AM
PaulGr PaulGr is offline
Involved in Discussions

 
Registration Date: Sep 2010
Location: Netherlands
 
Posts: 42
Thanks Given to Others: 6
Thanked 22 Times in 18 Posts
Karma Power: 21
Karma: 120
PaulGr is appreciated, and has over 100 Karma points.PaulGr is appreciated, and has over 100 Karma points.
Re: EU Country Specific Medical Device Registration Requirements

A recent article in the MPO also indicated registration requirements for Spain:
http://www.mpo-mag.com/articles/2011...opean-vacation

I am still believing that these registrations are only for reimbursing purposes and that just the sales is allowed by CE as explained by SteveK.

If my view is wrong, I would appreciate if someone could clarify on this.

Cheers, Paul
Thanks to PaulGr for your informative Post and/or Attachment!
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
Medical Device Registration Requirements in ASIAN Countries LQ. Fanny Lozano Other Medical Device Regulations World-Wide 20 10th October 2012 11:08 PM
Thailand Medical Device Registration Requirements LQ. Fanny Lozano Other Medical Device Regulations World-Wide 4 30th September 2011 01:59 PM
Medical Device Import/Export Translation Requirements for each country KAMay EU Medical Device Regulations 25 3rd January 2011 09:28 AM
Country CE Mark Registration Requirements in EU (France and Germany) biomargam CE Marking (Conformité Européene) / CB Scheme 7 22nd September 2010 10:01 PM
Medical Device Registration requirements for Algeria and Libya schorre ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 2 22nd July 2008 09:44 AM



The time now is 02:12 PM. 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