THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS EUDAMED...

THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTSMEDICAL DEVICES AND BIOCIDAL PRODUCTS

www.urpl.gov.plwww.urpl.gov.pl

EUDAMED – EUDAMED – Polish experiencePolish experience

Anna SarnowskaAnna SarnowskaDepartment for Information on Medical DevicesDepartment for Information on Medical Devices

THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTSTHE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS


EUDAMED – general purposeEUDAMED – general purpose

COMMISSION DECISION of 19 April 2010 on the COMMISSION DECISION of 19 April 2010 on the European Databank on Medical Devices (Eudamed)European Databank on Medical Devices (Eudamed)(Commission Decision 2010/227/EU - OJ L 102/45 of 23.04.2010)(Commission Decision 2010/227/EU - OJ L 102/45 of 23.04.2010)

to to strengthen market surveillance strengthen market surveillance by providing competent by providing competent authorities with fast access to information on manufacturers authorities with fast access to information on manufacturers

and authorised representatives, devices and certificates and to and authorised representatives, devices and certificates and to vigilance data, to share information on clinical investigation vigilance data, to share information on clinical investigation

data, as well as to contribute to a data, as well as to contribute to a uniformuniform application of those application of those Directives, in particular in relation to Directives, in particular in relation to registration requirementsregistration requirements



EUDAMED – minimum data EUDAMED – minimum data requiredrequired Actors (M, AR) Actors (M, AR) rolerole

namename

street, locality, postcode, countrystreet, locality, postcode, country

phone or e-mailphone or e-mail DevicesDevices internationally recognised nomenclature codeinternationally recognised nomenclature code

device name (generic name)device name (generic name) Certificates Certificates number, type, date of issue, expiration datenumber, type, date of issue, expiration date

actors dataactors data

Notified Body General Scope Notified Body General Scope description description

details on device details on device

status, reasons for decision of Notified status, reasons for decision of Notified BodyBody

Medical Medical incidentsincidents Clinical investigationsClinical investigations



Implementation of the DecisionImplementation of the Decision

01 May 2011 30 April 2012

entering data according to the Decision

entering data existing before the Decision

Poland had to adjust local law taking into account data needed for Poland had to adjust local law taking into account data needed for Eudamed and mandatory use of Eudamed fromEudamed and mandatory use of Eudamed from 11stst May 2011 May 2011



Impact of the Decision for Polish law Impact of the Decision for Polish law

Act on medical devices 20Act on medical devices 20thth May 2010 (Official Journal of Laws May 2010 (Official Journal of Laws 2010, No 107, item 679 as amended)2010, No 107, item 679 as amended)

New requirements in relation to data collected in Polish data New requirements in relation to data collected in Polish data base (e.g. GMDN or other internationally recognised base (e.g. GMDN or other internationally recognised nomenclature code, description of the device in English)nomenclature code, description of the device in English)

President of the Office is responsible for entering data to President of the Office is responsible for entering data to Eudamed (art. 48 – clinical trial; art. 64 – manufacturers/ Eudamed (art. 48 – clinical trial; art. 64 – manufacturers/ authorised representatives, devices, 83 - incidents, … art. authorised representatives, devices, 83 - incidents, … art. 141 provisions of mentioned articles shall be met from 1141 provisions of mentioned articles shall be met from 1stst May 2011)May 2011)

Supportive act on notification forms taking into account Supportive act on notification forms taking into account data needed for Eudameddata needed for Eudamed



Technical problemsTechnical problems

Eudamed predicted 4000 characters for enetering data Eudamed predicted 4000 characters for enetering data concerning model and description of the deviceconcerning model and description of the device 11stst restriction: model and description reduced from 4000 restriction: model and description reduced from 4000

characters to 2500characters to 2500 22ndnd restriction: model reduced from 2500 characters to 600 restriction: model reduced from 2500 characters to 600

problem with entering already collected data which have more problem with entering already collected data which have more characters than restrictedcharacters than restricted

Article 4 of the decision - 2 ways of data entryArticle 4 of the decision - 2 ways of data entry on-line data entryon-line data entry up-loading of XML filesup-loading of XML files

up-loading XML files difficult in practiceup-loading XML files difficult in practice data collected in Polish data base cannot be easily transferreddata collected in Polish data base cannot be easily transferred on-line data entry takes a lot of timeon-line data entry takes a lot of time



Internationally recognised nomenclatureInternationally recognised nomenclature

Article 4 of the decision - Member States shall ensure that Article 4 of the decision - Member States shall ensure that when entering data into Eudamed medical devices are when entering data into Eudamed medical devices are described using a code from an internationally recognised described using a code from an internationally recognised nomenclature for medical devices.nomenclature for medical devices. What means „internationally recognised nomenclature?What means „internationally recognised nomenclature? Preferred nomenclature – Global Medical Devices Preferred nomenclature – Global Medical Devices

Nomenclature (GMDN)Nomenclature (GMDN)

Problems reported by manufacturers in relation to GMDN use:Problems reported by manufacturers in relation to GMDN use:

! Difficult accessDifficult access

! Difficult use in practiceDifficult use in practice

! Expensive access Expensive access

! Language problemLanguage problem

EDMA, UMDNS, EDMA, UMDNS, AMDNS, CND instead AMDNS, CND instead

of GMDNof GMDN



GMDNGMDN CASE STUDY 1CASE STUDY 1

PL received information from NB about issued certificatePL received information from NB about issued certificate GMDN code 30004GMDN code 30004 During entering data GMDN not found in EudamedDuring entering data GMDN not found in Eudamed

? Is the code appropriateIs the code appropriate? If no, should we inform NB about mistake, should NB If no, should we inform NB about mistake, should NB

correct the certificatecorrect the certificate? If yes, how should we enter the codeIf yes, how should we enter the code

Codes given by NB in certificate are used by manufacturersCodes given by NB in certificate are used by manufacturers While entering data from certificate data concerning device are created – While entering data from certificate data concerning device are created –

GMDN or other code mandatoryGMDN or other code mandatory



Actors dataActors data

CASE STUDY 2CASE STUDY 2 Poland created data for a manufacturerPoland created data for a manufacturer During searching Eudamed occurs that data were During searching Eudamed occurs that data were

previously created by other MSpreviously created by other MS Data entered by other MS are incorrectData entered by other MS are incorrect

? What about multiple entered dataWhat about multiple entered data? Should we inform other MB state that entered data are Should we inform other MB state that entered data are

incorrectincorrect? Should we take into consideration specific language character Should we take into consideration specific language character

while entering datawhile entering data



EMO - FARM spółka z ograniczoną EMO - FARM spółka z ograniczoną odpowiedzialnościąodpowiedzialnością

Łódzka Łódzka 15715795-054 95-054 KsawerówKsawerów+48+48 42 42 2215 83 0415 83 04

[email protected]@emo-farm.pl

E M OE M OUL LodzkaUL Lodzka 157 157

95-054 95-054 Ksawerow K/lod21Ksawerow K/lod21042 158 304042 158 304

no e-mailno e-mail

Data entered by other MSData entered by other MS Data entered by PLData entered by PL



Actors dataActors data CASE STUDY 3CASE STUDY 3

Other MS entered data concerning Polish manufacturerOther MS entered data concerning Polish manufacturer PL took the information about change in manufacturer’s addressPL took the information about change in manufacturer’s address The owner of manufacturer’s data is other MSThe owner of manufacturer’s data is other MS

"Aqua-Med" Zakład "Aqua-Med" Zakład Produkcji Art. Produkcji Art. Medycznych Kolasa Medycznych Kolasa Spółka JawnaSpółka Jawnaul. ul. Targowa 55Targowa 5590-32390-323 Łódź Łódź

"Aqua-Med" Zakład "Aqua-Med" Zakład Produkcji Art. Produkcji Art. Medycznych Kolasa Medycznych Kolasa Spółka JawnaSpółka Jawnaul. ul. WólczańskaWólczańska 212 21290-53190-531ŁódźŁódź

Aqua--Med zpamAqua--Med zpamwolczanska wolczanska 21221290-53190-531LODZLODZ

Should we inform other MS that data entered by them have changed?Should we inform other MS that data entered by them have changed?

Existing dataExisting data Correct dataCorrect data Data after changeData after change



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 EUDAMED...

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