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;
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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.
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.
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: [email protected]: 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: [email protected] Web: http://www.ages.at/
Surveillance and registration authority
Österreichisches Bundesinstitut für Gesundheitswesen - ÖBIG (Austrian Federal Institute for Community Health)Medizinprodukteregister (Medical Devices Registry)
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)
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
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
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
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)
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: [email protected]: 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)
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.
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).
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)
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)
Lietuvos standatizacijos departamentas (Lithuanian Standards Board)
T. Kosciuškos g. 30LT-01100 VilniusTel: (+370) 5 212 62 52Fax: (+370) 5 212 62 52E-mail: [email protected]: 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)