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Technical standards for in vitro diagnostic medical devices

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					Technical standards for in vitro diagnostic medical
devices
The placing of in vitro medical devices on the European Union (EU) market is subject to the
compliance with the essential requirements established by Directive 98/79/EC (OJ L-331
07/12/1998) in order to ensure a high level of protection of the health and safety of patients, users
and third parties and achieve the intended level of performance.

Product scope
Directive 98/79/EC (OJ L-331 07/12/1998) applies to in vitro diagnostic medical devices and
their accessories. These devices are products to be used for the in vitro analysis of tissues or
substances (blood, specimens) from the human body with the objective of:

       providing information of the state of health or congenital diseases or anomalies
       determining the compatibility in the case of organ or blood donations
       monitoring therapeutic measures

Examples of in vitro diagnostic medical devices are equipment for blood analysis, pregnancy
tests, laboratory equipment intended for in vitro diagnostic examination, etc.

Products for general laboratory use are excluded.

1. Essential requirements
The medical devices must meet the mandatory essential requirements set out in Annex I to the
Directive in such a way that their design, manufacture and packaging minimise any risks to the
safety and health of patients, users and third parties when they are used for their intended
purpose.

These requirements refer to issues such as chemical and physical properties (e.g. compatibility
between the materials and the specimens), environmental properties, sterilization, accuracy of
devices with a measuring function, labelling or instructions for use.

In particular the label must bear the following particulars:

    a. the name and address of the manufacturer;
    b. the details strictly necessary for the user to identify the device and the contents of the
       packaging;
    c. where appropriate, the word 'STERILE';
    d. where appropriate, the batch code, preceded by the word 'LOT', or the serial number;
    e. where appropriate, an indication of the date by which the device should be used, in
       safety, expressed as the year and the month;
    f. in case of devices for performance evaluation, the words 'for performance evaluation
       only'
    g. where appropriate, a statement indicating the in vitro use of the device;
    h. any special storage and/or handling conditions; operating instructions; warnings and/or
       precautions to take;
    i. year of manufacture for active devices;
    j. where applicable, method of sterilization;
    k. if the device is intended for self-testing, that fact must be clearly stated.
The esential requirements cover risks such as injuries, infection and microbial contamination,
radiation, electromagnetic disturbances, environmental risks, electrical risks, mechanical and
thermal risks, risks of fire and explosion, etc.

2. Harmonised standards
 Harmonised standards are technical specifications that would enable to meet the essential
 requirements. Products manufactured according to these harmonised standards benefit from a
 presumption of compliance with the essential requirements.

 Harmonised standards are developed by the European Standardisation bodies: The European
 Committee for standardisation (CEN) and the European Committee for Electrotechnical
 standardisation (CENELEC) and published in the Official Journal of the European
 Communities.

3. Conformity assessment procedure
The conformity of most products falling under the scope of this Directive can be assessed by the
manufacturer himself since they do not constitute a direct risk to patients. The manufacturer
must draw up a document (EC declaration of conformity) declaring that the products concerned
meet the essential requirements of the Directive. He must also prepare the technical
documentation described in Annex III and ensure that the manufacture follows the principles of
quality assurance.

Categories of products included in Annex II (e.g. products used in blood transfusion,
identification of AIDS, measurement of blood sugar, etc.) need the intervention of a third party
(Notified Body) at the design and production stages. The procedures vary according to the
classification (Class A or B) of the product.

Devices for self-testing by the user always require an examination of the design by a Notified
Body, even if they are not included in Annex II.

Notified bodies are organisations designated by each Member State and notified to the
Commission and the other Member States, that are in charge of assesing manufaturer's
conformity to the esssential requirements when a third party is required.

4. CE Marking
Devices considered to meet the essential requirements must bear the CE marking of
conformity when they are placed on the market. It must appear in a visible, legible and indelible
way on the device or its pack and on the instructions for use. The CE marking shall be
accompanied by the identification number of the notified body in charge of the conformity
assessment procedure, where the intervention of a third party is needed.

Devices to be used as testing material in performance evaluation studies shall not bear the CE
Marking. They must be accompanied by a statement drawn up by the manufacturer declaring
that the product fulfils the essential requirements of the Directive. The contents of this statement
are detailed in Annex VIII.

5. Other obligations
A. Registration of representatives and devices

Any manufacturer who places these devices on the EU market and does not have a registered
place of business in a Member State, must designate an authorised representative within the
European Union. The authorised representative must register with the competent authorities of
the Member State in which he is established.

B. Notification of putting into service

Member States may request further information on devices covered by Annex II and on devices
for self-testing when they are put into service within their territory (data allowing identification
together with the label and the instructions).

6. Market surveillance
Each Member State establishes authorities to be responsible for checking that devices placed on
the market meet the requirements of the Directive and that the affixing and use of the CE
marking is correct.

In case a Member State finds that the CE Marking has been affixed unduly, the manufacturer or
his authorised representative established within the EU must make the product conform to the
essential safety requirements. Otherwise, the Member State must restrict or forbid the placing on
the market of those devices which are liable to endanger the health and/or safety of patients,
users and third parties.

Member States customs authorities shall also control the conformity of the devices to the
essential requirements at the points of entry into the EU.

Legislation
  Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in
  vitro diagnostic medical devices (OJ L-331 07/12/1998)

Other information sources
  European Commission - DG Enterprise and Industry:
  http://europa.eu.int/comm/enterprise/medical_devices/index_en.htm




Additional information for Austria
  The details on the label and the instructions for use shall be written at least in German.

Competent authorities / competent bodies

Management authorities
      Bundesministerium für Gesundheit und Frauen - BMGF (Federal Ministry for Health and
       Women)
       Radetzkystraße 2
       AT-1031 Wien
       Tel: (+43) 1 711 00-0
       Fax: (+43) 1 711 00-14300
       E-mail: buergerservice@bmgf.gv.at
       Website: http://www.bmgf.gv.at
      Österreichische Agentur für Gesundheit und Ernährungssicherheit (Agency for Health
       and Food Safety)
       Spargelfeldstrasse 191
       AT-1220 Wien
       Tel: +430 50 555-444 /+431 73216
       Fax: +430 50 555-25025
       E-mail: communications@ages.at
       Web: http://www.ages.at/

Surveillance and registration authority

  Österreichisches Bundesinstitut für Gesundheitswesen - ÖBIG (Austrian Federal Institute for
  Community Health)
  Medizinprodukteregister (Medical Devices Registry)

  Stubenring 6
  AT-1010 Wien
  Tel: (+43) 1 51 561
  Fax: (+43) 1 51 38472
  E-mail: medizinprodukte@oebig.at
  Website: http://www.oebig.at

Standardisation body

  Österreichisches Normungsinstitut - ON (Austrian Standards Institute)

  Heinestraße 38
  AT-1020 Wien
  Tel: (+43) 1 213 00 0
  Fax: (+43) 1 213 00 818
  E-mail: office@on-norm.at
  Website: http://www.on-norm.at

Notified bodies

  http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main

Legislation
      Verordnung über die Klassifizierung von Medizinprodukten - BGBl. Teil II nr. 381/2000 -
       Order on Classification of the Medical Products
      Bundesgesetz betreffend Medizinprodukte (Medizinproduktegesetz - MPG) - BGBl., Nr.
       657/1996 (1996-11-29) - Law on Medical Products
     Verordnung über die grundlegenden Anforderungen an Medizinprodukte -BGBl. Teil II nr.
      9/2001 - (2001-01-05) - Order on Requirements for Medicine Products
     Verordnung über die Klassifizierung von Medizinprodukten - BGBl. Teil II nr. 381/2000 -
      Order on Classification of the Medical Products




Additional information for Belgium
Labelling requirements
 The information provided to the user must be at least in the three national languages (French,
 Dutch and German).

Registration and notification requirements
 For devices for self-testing and those listed in Annex II to Directive 98/79/EC manufacturers
 must provide the following information on the certification procedure: certification number, date
 of issue, identification number of the notified body involved and annex against which the
 certificate was issued. Additionally all data related to analytical or diagnostic parameters and
 the outcome of performance evaluations must be available in the instructions for use and kept
 by the manufacturer.

Competent authority / competent bodies

Management and registration authority

 Wetenschappelijk Instituut Volksgezondheid / Institut Scientifique de la Santé Publique
 (Scientific Institute of Public Health)
 Departament klinische biologie / Section Biologie Clinique (Department of Clinical Biology)

 Rue Juliette Wytsman, 14
 B-1050 Brussel / Bruxelles
 Tel: (+32) 2 642 55 21 / (+32) 2 642 55 11
 Fax: (+32) 2 642 56 45 / (+32) 2 642 50 01
 Website: http://www.iph.fgov.be/

Standardisation bodies

 Competent body for homologation and registration of standards

 Belgisch Instituut voor Normalisatie – BIN / Institut Belge de Normalisation - IBN (Belgian
 Institute for Standardisation)

 Brabançonnelaan / Avenue de la Brabançonne 29
 B-1000 Brussel / Bruxelles
 Tel: (+32) 2 738 01 11 / (+32) 2 738 01 12
 Fax: (+32) 2 733 42 64
 E-mail: info@ibn.be
 Website: http://www.ibn.be/

 Competent body for standardisation in the field of electricity

 Belgisch Elektrotechnisch Comité – BEC / Comité Electrotechnique Belge - CEB (Belgian
 Electrotechnical Committee)

 August Reyerslaan 80 / Boulevard Auguste Reyers 80
 B-1030 Brussel / Bruxelles
 Tel: (+32) 2 706 85 70
 Fax: (+32) 2 706 85 80
 E-mail: centraloffice@bec-ceb.be
 Website: http://www.bec-ceb.be/

Legislation
 Arrêté royal of 18/03/1999 on Medical Devices (MB of 14/04/1999)




Additional information for Cyprus
Labelling requirements
 The details on the label and the instructions for use shall be written at least in Greek. English is
 accepted for professional use devices

Competent authority / competent bodies

Management, surveillance and registration authority

 Ypourgeio Ygeias (Ministry of Health)
 Iatrikes Ypiresies kai Ypiresies Dimosias Ygeias (Medical and Public Health Services)

 John Keneddy 18
 CY-1046 Nicosia
 Tel: (+357) 22 305 339
 Fax: (+357) 22 305 345
 E-mail: cymda@mphs.moh.gov.cy
 Website: http://www.moh.gov.cy

Standardisation body

 Kypriakos Organismos Typopoiisis (Cyprus Organisation for Standardisation)

 Corner of Leoforos Lemesou and Kosta Anaxagora 30
 CY-2014 Nicosia
 Tel: (+357) 22 411 411
  Fax: (+357) 22 411 511
  E-mail: cystandards@cys.org.cy
  Website: http://www.cys.org.cy

Legislation
Regulation 597/2003, on in vitro diagnostic medical devices (EE 18/07/2003)




Additional information for the Czech Republic
Labelling requirements
  The details on the label and the instructions for use shall be written at least in Czech.

Competent authorities / competent bodies

Management authority

  Ministerstvo zdravotnictví ČR (Ministry of Health of the Czech Republic)

  Palackého nám. 4
  CZ-128 01 Praha
  Tel: (+420) 224 971 111
  Fax: (+420) 224 972 111
  E-mail: mzcr@mzcr.cz
  Website: http://www.mzcr.cz

Surveillance and registration authority

  Státní ústav pro kontrolu léčiv (State Institute for Drug Control)

  Šrobárova 48
  CZ-100 41 Praha
  Tel: (+420) 272 185 111
  Fax: (+420) 272 185 744
  E-mail: sukl@sukl.cz
  Website: http://www.sukl.cz

Standardisation body

  Český normalizační institut - ČNI (Czech Standards Institute)

  Biskupský dvůr 5
  CZ-110 02 Praha
  Tel: (+420) 221 802 111
 Fax: (+420) 221 802 301
 E-mail: info@cni.cz
 Website: http://www.cni.cz

Notified bodies

 http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main

Legislation
      Nařízení vlády, kterým se stanoví technické poţadavky na zdravotnické prostředky
       (č.336/2004 Sb.), 5. 5. 2004 (Order on Technical Requirements for Medical Devices)
      Zákon o technických poţadavcích na výrobky (č. 22/1997 Sb.), 24. 1.1997 (Law on
       Technical Requirements for Products)
      Zákon o zdravotnických prostředcích (č. 123/2000 Sb.), 15. 4.2000 (Law on Medical
       Devices)
      Zákon o obecné bezpečnosti výrobku (č. 102/2001 Sb.), 22. 2.2001 (Law on Safety of
       Products)
      Nařízení vlády, kterým se stanoví technické poţadavky na diagnostické zdravotnické
       prostředky in vitro (č. 453/2004 Sb.), 7. 7.2004 (Order on Technical Requirements for
       Medical Diagnostic Devices in Vitro)




Additional information for Denmark
Labelling requirements
 The details on the label and the instructions for use shall be written at least in Danish.

Competent authority / competent bodies

Management, surveillance and registration authority

 Lægemiddelstyrelsen (Danish Medicines Agency)

 Axel Heides Gade 1
 DK-2300 Copenhagen S
 Tel: (+45) 4488 9595
 Fax: (+45) 4488 9599
 E-mail: dkma@dkma.dk
 Website: http://www.dkma.dk

Standardisation body

 Dansk Standard (Danish Standards Association)
 Kollegievej 6
 DK-2920 Charlottenlund
 Tel: (+45) 3996 6101
 Fax: (+45) 3996 6102
 E-mail: dansk.standard@ds.dk
 Website: http://www.ds.dk

Notified bodies

 http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main

Legislation
      BEK nr 1268 of 12/12/2005. Order on medical devices
      BEK nr 1269 of 12/12/2005. Order on medical devices used in in-vitro diagnoses
      Bekendtgørelse om medicinsk udstyr till in vitro-diagnostik (Order on Medical Devices for
       In Vitro Diagnoses, Lovtidende BEK nr 1171 af 17/12/2002)




Additional information for Estonia
Labelling requirements
 The details on the label and the instructions for use shall be written at least in Estonian.

Competent authority / competent bodies

Management authority, surveillance and registration authority

 Ravimiamet (State Agency of Medicines)

 Ülikooli 1
 EE-51003 Tartu
 Tel: (+372) 7441 565
 Fax: (+372) 7441 099
 E-mail: sam@sam.ee
 Website: http://www.sam.ee

Standardisation body

 Eesti Standardikeskus MTÜ (Estonian Centre for Standardisation)

 Aru 10
 EE-10317 Tallinn
 Tel: (+372) 6055 050
 Fax: (+372) 6055 070
 E-mail: info@evs.ee
 Website: http://www.evs.ee
Legislation
      Olulised nõuded meditsiiniseadmele, selle klassi määramise alused ja
       vastavushindamise protseduurid - Requirements for Medical Devices of 01/06/2000 (RTL
       2000, 63, 997)
      Meditsiiniseadme kasutussevõtmise ja kasutamise eeskirja kinnitamine - Regulations of
       Putting into Service and Usage of Medical Devices of 13/07/1999 (RTL 1999, 115, 1522)
      Meditsiiniseadme kasutamisel ohujuhtumist teavitamine - Regulation on the Obligation of
       Reporting Dangerous Situations while Operating Dangerous Medical Devices of
       28/02/2001 (RTL 2001, 35, 470)
      Ohujuhtumist teavitamise kord ja teavitamisvormid - Forms and Requirements of
       reporting Dangerous Situations of 25/11/2004 (RTL 2004, 149, 2271)
      Meditsiiniseadme turule laskmisest ja meditsiiniseadmel tehtud olulistest muudatustest
       teavitamise tingimused ja kord - Requirements about reporting for Medical Devices and
       on Placing on the Market of 25/11/2004 (RTL 2004, 149, 2270)
      Nõuded meditsiiniseadme kavandamisele, tootmisele, pakendamisele ja
       meditsiiniseadmega kaasnevale teabele1 - Requirements on Design, Production,
       Packaging and Labelling of Medical Devices of 13/12/2004 (RTI 2004, 85, 580)
      Meditsiiniseadme vastavushindamise kord1 - Regulation on the Evaluation of Medical
       Devices of 13/12/2004 (RT I 2004, 85, 581)
      Meditsiiniseadmete liigitamise reeglid - Regulation on Different Types of Medical Devices
       of 26/11/2004 (RT I 2004, 82, 558)
      Meditsiiniseadme seadus - Medical Devices Act of 13/10/2004 (RT I, 2004, 75, 520)
      Ravimiseadus - Medicinal Products Act of 16/12/2004 (RT I 2005, 2, 4)
      Kunstliku Viljastamise ja embruokaitse seadus - Artificial Insemination and Embryo
       Protection Act (RT I 1997, 51, 824)




Additional information for Finland
Labelling requirements
 The details on the label and the instructions for use shall be written at least in Finnish and
 Swedish.

Competent authority / competent bodies

Management, surveillance and registration authority

 Lääkelaitos (National Agency for Medicines)

 P.O.Box 55
 FI-Helsinki 00301
 Tel: (+358) 9 473 341
 Fax: (+358) 9 714 469
 E-mail: communications@nam.fi
 Website: http://www.nam.fi
Standardisation body

 Suomen Standardisoimisliitto - SFS (Finnish Standards Association)

 P.O.Box 116
 FI-Helsinki 00241
 Tel: (+358) 9 149 9331
 Fax: (+358) 9 146 4925
 E-mail: sfs@sfs.fi
 Website: http://www.sfs.fi

Notified bodies

 http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main

Legislation
      Valtioneuvoston asetus in vitro -diagnostiikkaan tarkoitetuista laitteista. Government
       Decree on In Vitro Medical Devices of 28 September 2000, (Suomen säädöskokoelma
       2000/830)
      Laki terveydenhuollon laitteista ja tarvikkeista. Medical Devices Act of 29 December
       1994, (Suomen säädöskokoelma 1994/1505)
      Sosiaali- ja terveysministeriön päätös aktiivista implantoitavista laitteista ja tarvikkeista.
       Decision of the Ministry of Social Security and Health on Active Implantable Medical
       Devices of 20 January 1994, (Sosiaali- ja terveysministeriön määräyskokoelma 1994/67)




Additional information for France
Labelling requirements
 Information on the labelling and instructions of in vitro diagnostic medical devices must be at
 least in French.

Registration and notification requirements
 Any person engaged in the marketing of auto-diagnosis devices and devices listed in Annex II
 to the EU Directive must register this activity to the AFSSAPS (French Standardisation
 Association).

Competent authority / competent bodies

Management, market surveillance and registration authority
 Agence française de sécurité sanitaire des produits de santé - AFSSAPS (French Agency of
 Health Safety on Medical Products)
 Direction de l'evaluation des dispositifs médicaux - DEDIM (DG of medical devices evaluation)

 143, boulevard Anatole France
 F-93285 Saint-Denis Cedex
 Tel: (+33) 1 55 87 37 45/ (+33) 1 55 87 30 00
 Fax: (+33) 1 55 87 37 42 / (+33) 1 55 87 30 12
 Website: http://afssaps.sante.fr/

Notified body

 G-MED - Groupement pour l'Évaluation des Dispositifs Médicaux (Group for Medical Devices
 Evaluations)
 Unité Technique Dispositifs Médicaux

 1, rue Gaston Boissier
 F-75724 Paris Cedex
 Tel: (+33) 1 40 43 39 72 / (+33) 1 40 43 37 00
 Fax: (+33) 1 40 43 37 37
 Website: http://www.gmed.fr/

Standardisation body

 Association française de normalisation - AFNOR (French Standardisation Association)

 11, Rue Francis de Pressensé
 F-93571 Saint-Denis la Plaine Cedex
 Tel: (+33) 1 41 62 80 00 / (+33) 1 41 62 76 44
 Fax: (+33) 1 49 17 90 00
 E-mail: norminfo@afnor.org
 Website: http://www.afnor.org

Legislation
      Ordonnance No. 2001-198 of 01/03/2001 on the transposition of Directive 98/79/CE of
       the European Parliament and of the Council of 27 October 1998 on medical devices for in
       vitro diagnosis (JO of 03/03/2001)
      Décret No. 2004-108 of 04/02/2004 on medical devices for in vitro diagnosis and
       amending the Public Health Code (JO No. 31 of 06/02/2004)




Additional information for Germany
 The details on the label and the instructions for use shall be written at least in German.

Competent authority / competent bodies
Management authority

  Bundesministerium für Gesundheit - BMG (Federal Ministry of Health)

  Am Probsthof 78a
  DE-53121 Bonn
  Tel: (+49) 1888 441 0
  Fax: (+49) 1888 441 4900
  E-mail: info@bmg.bund.de
  Website: http://www.bmg.bund.de

Surveillance and registration authority

  Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM (Federal Institute for Drugs and
  Medical Devices)

  Kurt-Georg-Kiesinger-Allee 3
  DE-53175 Bonn
  Tel: (+49) 228 207 30
  Fax: (+49) 228 207 5207
  E-mail: poststelle@bfarm.de
  Website: http://www.bfarm.de

Standardisation body

  Deutsches Institut für Normung - DIN (German Standardisation Institute)

  Burggrafenstraße 6
  DE-10787 Berlin
  Tel: (+49) 30 2601 0
  Fax: (+49) 30 2601 1231
  Website: http://www.din.de

Notified bodies

  http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main

Legislation
  Gesetz über Medizinprodukte - MPG - BGBl I 1994, 1963, 2.8.1994 (Law on Medical Products)
Additional information for Greece
Labelling requirements
 The details on the label and the instructions for use shall be written at least in Greek.

Competent authority / competent bodies

Management authority, surveillance and registration authority

 Ethnikos Organismos Farmakon - EOF (National Organization for Medicines)

 Messogion Av. 284
 GR-15562 Athens
 Tel: (+30) 210 65 07200 / 210 65 07206
 Fax: (+30) 210 65 45534 / 210 65 45535
 E-mail: relation@eof.gr
 Website: http://www.eof.gr

Standardisation body

 Ellinikos Organismos Typopoiisis - ELOT (Hellenic Organization for Standardization)

 Acharnon Street 313
 GR-11145 Athens
 Tel: (+30) 210 212 0100
 Fax: (+30) 210 228 3034
 E-mail: info@elot.gr
 Website: http://www.elot.gr

Notified bodies

 http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main




Additional information for Hungary
Labelling requirements
 The details on the label and the instructions for use shall be written at least in Hungarian.

Competent authority / competent bodies

Management authority
  Egészségügyi Minisztérium - EüM (Ministry of Health)

  Arany János u. 6-8.
  HU-1051 Budapest
  Tel: (+36) 1 301 7800
  Fax: (+36) 1 302 0925
  E-mail: ugyfelszolgalat@eum.hu
  Website: http://www.eum.hu

Surveillance and registration authority

  Egészségügyi Engedélyezési és Közigazgatási Hivatal (Office of Health Authorisation and
  Administrative Procedures)

  Zrínyi u. 3.
  HU-1051 Budapest
  Fax: (+36) 1 269 3794
  E-mail: ekh.titk@eum.hu
  Website: http://www.eekh.hu

Standardisation body

  Magyar Szabványügyi Testület - MSZT (Hungarian Standards Institution)

  Ülloi str. 25.
  HU-1091 Budapest
  Tel: (+36) 1 456 6800
  Fax: (+36) 1 456 6884
  E-mail: mszinfo@mszt.hu
  Website: http://www.mszt.hu

Legislation
  8/2003. (III. 13.) ESzCsM rendelet az in vitro diagnosztikai orvostechnikai eszközökrol




Additional information for Ireland
Labelling requirements
  The information and particulars of the label must be in English (whether or not they are also in
  another language and whether or not the device is for professional or other use).

Registration and notification requirements
  In-vitro diagnostic medical devices must be registered with the Medical Devices Department
  within the IMB.
 Self testing devices and devices included in Annex II to the EU Directive require additional
 information: the description of the device, the analytical and, where appropriate, diagnostic
 parameters together with a copy of the label and the instructions for use.

Competent authority / competent bodies

Management and registration authority

 Irish Medicines Board (IMB)
 Medical Devices Department

 Earlsfort Centre
 Earlsfort Terrace
 Dublin 2, Ireland
 Tel: (+353) 1 676 4971
 Fax: (+353) 1 634 4033
 Email: medicaldevices@imb.ie
 Website: http://www.medicaldevices.ie/

Standardisation and notified body

 National Standards Authority of Ireland (NSAI)

 Glasnevin
 Dublin 9, Ireland
 Tel: (+353) 1 807 3800
 Fax: (+353) 1 807 3838
 E-mail: nsai@nsai.ie
 Website: http://www.nsai.ie/

Legislation
 European Communities (In-vitro Diagnostic Medical Devices) Regulations, 2001 (S.I. No. 304
 of 2001)




Additional information for Italy
 The information of the label must be in Italian, whether or not the device is for professional or
 other use.

Additional registration and notification requirements
 Representatives established in Italy who put in vitro diagnostic medical devices on the market
 must register with the Ministero della Salute (Ministry of Health).
Competent authority / competent bodies

Management and registration authority

 Ministero della Salute (Ministry of Health)
 Dipartimento dell'innovazione (Department of Innovation)
 Direzione Generale dei Farmaci e Dispositivi Medici (Directorate-General of Pharmacy and
 Medical Devices)
 Ufficio Diagnostici Invitro (In Vitro Diagnostic Office)

 Viale della Civiltà Romana 7
 I-00144 Roma
 Tel: (+39) 06 59941 / 06 59943508
 Fax: (+39) 06 59943266 / 06 59943776
 E-mail: CSD-Sanita@tsf.it
 Website: http://www.ministerosalute.it/

Standardisation bodies

 General standardisation

 Ente Nazionale Italiano di Unificazione - UNI (Italian National Standardisation Body)

 Via Sannio, 2
 I-20135 Milano
 Tel: (+39) 02 700241
 Fax: (+39) 02 7002 4375
 E-mail: uni@uni.com
 Website: http://www.uni.com/

 Standardisation in the electrotechnical field

 Comitato Elettrotecnico Italiano - CEI (Italian Electro-Technical Committee)

 Via Saccardo, 9
 I-20134 Milano
 Tel: (+39) 02 210061
 Fax: (+39) 02 210062 10
 E-mail: cei@ceiweb.it
 Website: http://www.ceiweb.it/

Legislation
 Decreto legislativo of 08/09/2000 No. 332, implementing Directive 98/79/EC on in vitro
 diagnostic medical devices (GURI n. 269, 17/11/2000. N. 189/L.)

Other Information Sources
 Guide on medical devices of the Ministry of Health:
 http://www.ministerosalute.it/dispositivi/dispomed.jsp
Additional information for Latvia
Labelling requirements
 The details on the label and the instructions for use shall be written at least in Latvian. English
 or German are accepted for professional use devices

Competent authority / competent bodies

Management, surveillance and registration authority as well as notified
body

 Veselības statistikas un medicīnas tehnoloģiju aģentūra - VSMTA (Health Statistics and
 Medicine Technologies State Agency)

 Duntes 12/22
 LV-1005 Riga
 Tel: (+371) 750 1590
 Fax: (+371) 750 1591
 E-mail: agentura@vsmta.lv
 Website: http://www.vsmta.lv

Standardisation body

 Latvijas standarts - LVS (Latvian Standards Ltd)

 K. Valdemāra iela 157
 LV-1013 Riga
 Tel: (+371) 737 1308
 Fax: (+371) 737 1324
 E-mail: lvs@lvs.lv
 Website: http://www.lvs.lv




Additional information for Lithuania
Labelling requirements
 The details on the label and the instructions for use shall be written at least in Lithuanian.

Competent authority / competent bodies

Management, surveillance and registration authority
 Valstybinė akreditavimo sveikatos priežiūros veiklai tarnyba - VASPVT (State Health Care
 Accreditation Agency)

 Ţ. Liauksmino g. 5
 LT-01101 Vilnius
 Tel: (+370) 5 262 96 07 / 5 261 51 77
 Fax: (+370) 5 212 73 10
 E-mail: vaspvt@takas.lt, medakred@post.omnitel.net
 Website: http://vaspvt.sam.lt

Standardisation body

 Lietuvos standatizacijos departamentas (Lithuanian Standards Board)

 T. Kosciuškos g. 30
 LT-01100 Vilnius
 Tel: (+370) 5 212 62 52
 Fax: (+370) 5 212 62 52
 E-mail: lstboard@lsd.lt
 Website: http://www.lsd.lt




Additional information for Luxembourg
Labelling requirements
 Labels must be written in Luxembourgish, French or German if the device is aimed to the
 particular use, though English is accepted for the professional use.

Registration and notification requirements
 In the case of devices referred to in Annex II of the Règlement, the Ministère de la Santé
 (Ministry of Health) must receive all data allowing the identification of the devices: the
 analytical and, where appropriate, diagnostic parameters.

Competent authority / competent bodies

Management and registration authority

 Ministère de la Santé (Ministry of Health)
 Division de la Médecine Curative (Curative Medicine Division)

 Villa Louvigny – allée Marconi
 L-2120 Luxembourg
 Tel: (+352) 478 56 34 / (+352) 4781
 Fax: (+352) 467 523 / (+352) 26 20 32 96
 E-mail: Ministere-Sante@ms.etat.lu
 Website: http://www.ms.etat.lu

Standardisation body

 Service de l'Energie de l'Etat - SEE (State Service of Energy)
 Organisme Luxembourgeois de Normalisation (Luxembourg Standardisation Body)

 B.P. 10
 L-2010 Luxembourg
 Tel: (+352) 46 97 46 1 / (+352) 46 97 46 30 / (+352) 46 97 46 50
 Fax: (+352) 46 97 46 39
 E-mail: see.normalisation@eg.etat.lu
 Website: http://www.see.lu/

Legislation
      Loi of 16 January 1990 regarding medical devices (Mémorial A 003 of 25/01/1990),
       amended by Loi of 20 June 2001 (Mémorial A 75 of 06/07/2001)
      Règlement grand-ducal of 24/07/2001 regarding in vitro diagnostic medical devices
       (Mémorial A 093 of 10.08.2001




Additional information for Malta
Labelling requirements
 The details on the label and the instructions for use shall be written at least in Maltese or in
 English.

Competent authority / competent bodies

Standardisation body and management, surveillance and registration
authority

 Malta Standards Authority - MSA
 Consumer and Industrial Goods Directorate - CIGD

 Evans Building
 Merchants Street
 MT-Valletta VLT 03
 Tel: (+356) 21 255 545 / 21 242 420
 Fax: (+356) 21 242 406
 E-mail: info@msa.org.mt
 Website: http://www.msa.org.mt/cigd
Legislation
     In Vitro Diagnostic Medical Devices Regulations, 2002, (Government Gazette of Malta
      No. 17,217 of 12/03/2002)
     Product Safety Act. (Government Gazette of Malta No. 17,052 of 09/02/2001)

				
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