THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS,
MEDICAL DEVICES AND BIOCIDAL PRODUCTS
EUDAMED – Polish experience
Anna Sarnowska
Department for Information on Medical Devices
www.urpl.gov.pl
THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
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 23.04.2010)
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
www.urpl.gov.pl
THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
EUDAMED – minimum data required
 Actors (M, AR)
 Devices
 Certificates
role
name
street, locality, postcode, country
phone or e-mail
internationally recognised nomenclature code
device name (generic name)
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
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
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
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
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
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
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
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
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
EDMA, UMDNS,
! Difficult use in practice
AMDNS, CND instead
! Expensive access
of GMDN
! Language problem
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
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
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
www.urpl.gov.pl
THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
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
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Data entered by other MS
Data entered by PL
EMO - FARM spółka z ograniczoną
odpowiedzialnością
Łódzka 157
95-054 Ksawerów
+48 42 215 83 04
emo@emo-farm.pl
EMO
UL Lodzka 157
95-054 Ksawerow K/lod21
042 158 304
no e-mail
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
www.urpl.gov.pl
THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
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 zpam
wolczanska 212
90-531LODZ
"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
90-323 Łódź
Should we inform other MS that data entered by them have changed?
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
www.urpl.gov.pl
THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
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
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
THANK YOU
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