1. EUDAMED – Polish experience Anna Sarnowska Department for Information on Medical Devices

2. EUDAMED – general purpose
COMMISSION DECISION of 19 April 2010 on the European Databank on Medical Devices (Eudamed)
(Commission Decision 2010/227/EU - OJ L 102/45 of )
to strengthen market surveillance by providing competent authorities with fast access to information on manufacturers and authorised representatives, devices and certificates and to vigilance data, to share information on clinical investigation data, as well as to contribute to a uniform application of those Directives, in particular in relation to registration requirements

3. EUDAMED – minimum data required
Actors (M, AR) role
name
street, locality, postcode, country
phone or
Devices internationally recognised nomenclature code
device name (generic name)
Certificates number, type, date of issue, expiration date
actors data
Notified Body General Scope description
details on device
status, reasons for decision of Notified Body
Medical incidents
Clinical investigations

4. Implementation of the Decision
01 May 2011
30 April 2012
entering data existing before the Decision
entering data according to the Decision
Poland had to adjust local law taking into account data needed for Eudamed and mandatory use of Eudamed from 1st May 2011

5. Impact of the Decision for Polish law
Act on medical devices 20th May 2010 (Official Journal of Laws 2010, No 107, item 679 as amended)
New requirements in relation to data collected in Polish data base (e.g. GMDN or other internationally recognised nomenclature code, description of the device in English)
President of the Office is responsible for entering data to Eudamed (art. 48 – clinical trial; art. 64 – manufacturers/ authorised representatives, devices, 83 - incidents, … art. 141 provisions of mentioned articles shall be met from 1st May 2011)
Supportive act on notification forms taking into account data needed for Eudamed

6. Technical problems
Eudamed predicted 4000 characters for enetering data concerning model and description of the device
1st restriction: model and description reduced from 4000 characters to 2500
2nd restriction: model reduced from 2500 characters to 600
problem with entering already collected data which have more characters than restricted
Article 4 of the decision - 2 ways of data entry
on-line data entry
up-loading of XML files
up-loading XML files difficult in practice
data collected in Polish data base cannot be easily transferred
on-line data entry takes a lot of time

7. Internationally recognised nomenclature
Article 4 of the decision - Member States shall ensure that when entering data into Eudamed medical devices are described using a code from an internationally recognised nomenclature for medical devices.
What means „internationally recognised nomenclature?
Preferred nomenclature – Global Medical Devices Nomenclature (GMDN)
Problems reported by manufacturers in relation to GMDN use:
Difficult access
Difficult use in practice
Expensive access
Language problem
EDMA, UMDNS, AMDNS, CND instead of GMDN

8. GMDN
CASE STUDY 1
PL received information from NB about issued certificate
GMDN code 30004
During entering data GMDN not found in Eudamed
Is the code appropriate
If no, should we inform NB about mistake, should NB correct the certificate
If yes, how should we enter the code
Codes given by NB in certificate are used by manufacturers
While entering data from certificate data concerning device are created – GMDN or other code mandatory

10. Actors data CASE STUDY 2 Poland created data for a manufacturer
During searching Eudamed occurs that data were previously created by other MS
Data entered by other MS are incorrect
What about multiple entered data
Should we inform other MB state that entered data are incorrect
Should we take into consideration specific language character while entering data

11. Data entered by other MS Data entered by PL
EMO - FARM spółka z ograniczoną odpowiedzialnością
Łódzka 157
Ksawerów
E M O
UL Lodzka 157
Ksawerow K/lod21 no

13. Actors data
CASE STUDY 3
Other MS entered data concerning Polish manufacturer
PL took the information about change in manufacturer’s address
The owner of manufacturer’s data is other MS
Existing data
Correct data
Data after change
"Aqua-Med" Zakład Produkcji Art. Medycznych Kolasa Spółka Jawna
ul. Wólczańska 212
90-531Łódź
"Aqua-Med" Zakład Produkcji Art. Medycznych Kolasa Spółka Jawna
ul. Targowa 55
Łódź
Aqua--Med zpam
wolczanska 212
90-531LODZ
Should we inform other MS that data entered by them have changed?

15. Conclusions
Specify what „internationally recognised nomenclature” means
Uniform the rules concerning usage of GMDN and other nomenclatures
Better exchange of information between Competent Authorities
Practical guideline concerning entering data into Eudamed needed

16. THANK YOU