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 AustriaThe 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 2AT-1031 WienTel: (+43) 1 711 00-0 Fax: (+43) 1 711 00-14300 E-mail: buergerservice@bmgf.gv.atWebsite: http://www.bmgf.gv.at

Österreichische Agentur für Gesundheit und Ernährungssicherheit (Agency for Health and Food Safety)Spargelfeldstrasse 191AT-1220 WienTel: +430 50 555-444 /+431 73216Fax: +430 50 555-25025E-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 6AT-1010 WienTel: (+43) 1 51 561Fax: (+43) 1 51 38472E-mail: medizinprodukte@oebig.atWebsite: http://www.oebig.at

Standardisation body

Österreichisches Normungsinstitut - ON (Austrian Standards Institute)

Heinestraße 38AT-1020 WienTel: (+43) 1 213 00 0Fax: (+43) 1 213 00 818E-mail: office@on-norm.atWebsite: 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, 14B-1050 Brussel / BruxellesTel: (+32) 2 642 55 21 / (+32) 2 642 55 11Fax: (+32) 2 642 56 45 / (+32) 2 642 50 01Website: 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 29B-1000 Brussel / BruxellesTel: (+32) 2 738 01 11 / (+32) 2 738 01 12Fax: (+32) 2 733 42 64E-mail: info@ibn.beWebsite: 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 80B-1030 Brussel / BruxellesTel: (+32) 2 706 85 70Fax: (+32) 2 706 85 80E-mail: centraloffice@bec-ceb.beWebsite: 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 18CY-1046 NicosiaTel: (+357) 22 305 339Fax: (+357) 22 305 345E-mail: cymda@mphs.moh.gov.cyWebsite: http://www.moh.gov.cy

Standardisation body

Kypriakos Organismos Typopoiisis (Cyprus Organisation for Standardisation)

Corner of Leoforos Lemesou and Kosta Anaxagora 30CY-2014 NicosiaTel: (+357) 22 411 411Fax: (+357) 22 411 511E-mail: cystandards@cys.org.cyWebsite: 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. 4CZ-128 01 PrahaTel: (+420) 224 971 111Fax: (+420) 224 972 111E-mail: mzcr@mzcr.czWebsite: http://www.mzcr.cz

Surveillance and registration authority

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

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

Standardisation body

Český normalizační institut - ČNI (Czech Standards Institute)

Biskupský dvůr 5CZ-110 02 PrahaTel: (+420) 221 802 111Fax: (+420) 221 802 301E-mail: info@cni.czWebsite: 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 požadavky na zdravotnické prostředky (č.336/2004 Sb.), 5. 5. 2004 (Order on Technical Requirements for Medical Devices)

Zákon o technických požadavcích 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 požadavky 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 1DK-2300 Copenhagen STel: (+45) 4488 9595Fax: (+45) 4488 9599E-mail: dkma@dkma.dkWebsite: http://www.dkma.dk

Standardisation body

Dansk Standard (Danish Standards Association)

Kollegievej 6DK-2920 CharlottenlundTel: (+45) 3996 6101Fax: (+45) 3996 6102

E-mail: dansk.standard@ds.dkWebsite: 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 1EE-51003 TartuTel: (+372) 7441 565Fax: (+372) 7441 099E-mail: sam@sam.eeWebsite: http://www.sam.ee

Standardisation body

Eesti Standardikeskus MTÜ (Estonian Centre for Standardisation)

Aru 10EE-10317 TallinnTel: (+372) 6055 050Fax: (+372) 6055 070E-mail: info@evs.eeWebsite: 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 55FI-Helsinki 00301Tel: (+358) 9 473 341Fax: (+358) 9 714 469E-mail: communications@nam.fiWebsite: http://www.nam.fi

Standardisation body

Suomen Standardisoimisliitto - SFS (Finnish Standards Association)

P.O.Box 116FI-Helsinki 00241Tel: (+358) 9 149 9331Fax: (+358) 9 146 4925E-mail: sfs@sfs.fiWebsite: 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 FranceF-93285 Saint-Denis CedexTel: (+33) 1 55 87 37 45/ (+33) 1 55 87 30 00

Fax: (+33) 1 55 87 37 42 / (+33) 1 55 87 30 12Website: 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 BoissierF-75724 Paris CedexTel: (+33) 1 40 43 39 72 / (+33) 1 40 43 37 00Fax: (+33) 1 40 43 37 37Website: http://www.gmed.fr/

Standardisation body

Association française de normalisation - AFNOR (French Standardisation Association)

11, Rue Francis de PressenséF-93571 Saint-Denis la Plaine CedexTel: (+33) 1 41 62 80 00 / (+33) 1 41 62 76 44Fax: (+33) 1 49 17 90 00E-mail: norminfo@afnor.orgWebsite: 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 GermanyThe 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 78aDE-53121 Bonn

Tel: (+49) 1888 441 0Fax: (+49) 1888 441 4900E-mail: info@bmg.bund.deWebsite: 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 3DE-53175 BonnTel: (+49) 228 207 30Fax: (+49) 228 207 5207E-mail: poststelle@bfarm.deWebsite: http://www.bfarm.de

Standardisation body

Deutsches Institut für Normung - DIN (German Standardisation Institute)

Burggrafenstraße 6DE-10787 BerlinTel: (+49) 30 2601 0Fax: (+49) 30 2601 1231Website: 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. 284GR-15562 AthensTel: (+30) 210 65 07200 / 210 65 07206Fax: (+30) 210 65 45534 / 210 65 45535E-mail: relation@eof.grWebsite: http://www.eof.gr

Standardisation body

Ellinikos Organismos Typopoiisis - ELOT (Hellenic Organization for Standardization)

Acharnon Street 313GR-11145 AthensTel: (+30) 210 212 0100Fax: (+30) 210 228 3034E-mail: info@elot.grWebsite: 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 7800Fax: (+36) 1 302 0925E-mail: ugyfelszolgalat@eum.huWebsite: 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 BudapestFax: (+36) 1 269 3794E-mail: ekh.titk@eum.huWebsite: http://www.eekh.hu

Standardisation body

Magyar Szabványügyi Testület - MSZT (Hungarian Standards Institution)

Ülloi str. 25.HU-1091 BudapestTel: (+36) 1 456 6800Fax: (+36) 1 456 6884E-mail: mszinfo@mszt.huWebsite: 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 TerraceDublin 2, IrelandTel: (+353) 1 676 4971Fax: (+353) 1 634 4033Email: medicaldevices@imb.ieWebsite: http://www.medicaldevices.ie/

Standardisation and notified body

National Standards Authority of Ireland (NSAI)

GlasnevinDublin 9, IrelandTel: (+353) 1 807 3800Fax: (+353) 1 807 3838E-mail: nsai@nsai.ieWebsite: http://www.nsai.ie/

Legislation

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

Additional information for ItalyThe 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 7I-00144 RomaTel: (+39) 06 59941 / 06 59943508Fax: (+39) 06 59943266 / 06 59943776E-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, 2I-20135 MilanoTel: (+39) 02 700241Fax: (+39) 02 7002 4375E-mail: uni@uni.comWebsite: http://www.uni.com/

Standardisation in the electrotechnical field

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

Via Saccardo, 9I-20134 MilanoTel: (+39) 02 210061Fax: (+39) 02 210062 10 E-mail: cei@ceiweb.itWebsite: 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 12/22LV-1005 RigaTel: (+371) 750 1590Fax: (+371) 750 1591E-mail: agentura@vsmta.lvWebsite: http://www.vsmta.lv

Standardisation body

Latvijas standarts - LVS (Latvian Standards Ltd)

K. Valdemāra iela 157LV-1013 RigaTel: (+371) 737 1308Fax: (+371) 737 1324E-mail: lvs@lvs.lvWebsite: 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)

Ž. Liauksmino g. 5LT-01101 VilniusTel: (+370) 5 262 96 07 / 5 261 51 77

Fax: (+370) 5 212 73 10E-mail: vaspvt@takas.lt, medakred@post.omnitel.netWebsite: http://vaspvt.sam.lt

Standardisation body

Lietuvos standatizacijos departamentas (Lithuanian Standards Board)

T. Kosciuškos g. 30LT-01100 VilniusTel: (+370) 5 212 62 52Fax: (+370) 5 212 62 52E-mail: lstboard@lsd.ltWebsite: 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 MarconiL-2120 LuxembourgTel: (+352) 478 56 34 / (+352) 4781Fax: (+352) 467 523 / (+352) 26 20 32 96E-mail: Ministere-Sante@ms.etat.luWebsite: 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. 10L-2010 LuxembourgTel: (+352) 46 97 46 1 / (+352) 46 97 46 30 / (+352) 46 97 46 50Fax: (+352) 46 97 46 39E-mail: see.normalisation@eg.etat.luWebsite: 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 - MSAConsumer and Industrial Goods Directorate - CIGD

Evans BuildingMerchants StreetMT-Valletta VLT 03Tel: (+356) 21 255 545 / 21 242 420Fax: (+356) 21 242 406E-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)