SCHEDULE B
GMDN Membership for Manufacturers (including Authorized Representative/Distributor Bodies)
Membership - Licence Details:
Definitions
For the purpose of this schedule, the following definition applies:
“Manufacturer” is an organisation that manufactures and/or supplies medical devices.
Member Access
Schedule ‘B’ Members will be able to access the GMDN database within which there are
at present approximately 19,000 generic terms. This includes some 9,000 “Preferred Terms” with full
definitions and these ‘P’ terms are those under which devices should be identified for regulatory
purposes. There are also approximately 1000 ‘CT’ terms (Collective Terms) which provide multiple links
for search processes, based on common features and applications. These ‘CT’ terms will form part of
the new GMDN “Navigator” system. The remaining 10,000 terms include ‘T’ terms which are
“Template Terms” and ‘S’ terms which are “Synonym Terms”, both of which provide
valuable search information to locate the appropriate ‘P’ term to be used. When the correct ‘P’ term
has been identified the appropriate code (5 digits) can be obtained using the “User Access” process.
Specific Licence Restrictions
This GMDN Membership gives the Member the right to access and use the GMDN Database, based on the
membership limitations within the Licensee’s company/environment for one year. This Licence must
be renewed each year in order to continue access to the GMDN Database.
GMDN Membership payment schedule includes continual updates of the GMDN Database and shall cover
a period of 12 months from date of issue.
This Membership restricts access to the GMDN Database to personnel employed and/or contracted by the
Member to work within the Manufacturer’s organisation.
Schedule ‘B’ - Manufacturer/Distributor Membership Fees (Subject to periodic review)
| Company Annual Medical Device Turnover, million € |
Fee, € |
Membership Annual Renewal Fees, € |
Includes Access to Codes for selected terms |
| 0.5 - 2 | 500 | 350 | 10 |
| 2 - 10 | 1200 | 800 | 15 |
| 10 - 100 | 1800 | 1200 | 20 |
| >100 | 2700 | 1800 | 25 |
Accessing GMDN Codes
Depending on the size of manufacturer and the number of devices for which the GMDN term code
(5 digits) is required, then each Manufacturer Member can obtain automatic link to and download codes
for all selected terms up to the number of generic descriptors authorised within one of the following
packs which have been purchased. In Proportion to the Member Company Turnover, free access to a number
of codes is provided for new Members.
SPECIAL MEMBERSHIP FOR SMALL MANUFACTURERS
| Small Manufacturer Membership |
Fee, €
(Payment only by Credit/Debit Card via. WorldPay) |
Membership Annual Renewal Fees, € |
Includes Access to 5 Codes for selected terms |
| Company Annual Medical Device Turnover < 0.5 million Euros (Evidence of turnover may be requested) |
200 |
100 |
5 |
Packs for GMDN Code Identification
| Pack Name | Pack Description | Pack Cost, € |
| Pack-P5 | User Access up to 5 codes total | 100 |
| Pack-P20 | User Access up to 20 codes total | 300 |
| Pack-P50 | User Access up to 50 codes total | 500 |
| Pack-P100 | User Access up to 100 codes total | 800 |
| Pack-P500 | User Access up to 500 codes total | 1500 |
| Pack-P1000 | User Access up to 1000 codes total | 2000 |
If not used in the current year all unused codes are available in the subsequent year for Members (Membership Licence to be renewed annually).
If all term codes from a given pack have been utilised, a further pack may be requested.
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IMPORTANT NOTE
UNDER THIS LICENCE IT IS FORBIDDEN TO SUPPLY GMDN CODES TO ANY PERSON OR PARTY OUTSIDE THE
CONFINES OF A MEMBERS LEGAL ENTITY, EITHER FOR PAYMENT OR FREE OF CHARGE, EXCEPT WHEN USE
OR TRANSFER BY A GMDN MEMBER OF CODES AND TERMS, IS FOR PURPOSES AS IMPLIED WITHIN THE SCOPE
OF THE LICENCE AS GRANTED.
FOR MEMBERS REQUESTING A FACILITY TO SUPPLY DATA WITH CODES TO A THIRD PARTY, PLEASE CONTACT
gmdn_agency@btinternet.com FOR A DEDICATED LICENCE.
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