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

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

EUDAMED – minimum data required Actors (M, AR) role name street, locality, postcode, country phone or e-mail 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

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

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

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

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

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

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

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 E M O UL Lodzka 157 95-054 Ksawerow K/lod21 042 158 304 no e-mail

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 90-323 Łódź Aqua--Med zpam wolczanska 212 90-531LODZ Should we inform other MS that data entered by them have changed?

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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