1 Specific labelling requirements under the In vitro diagnostic medical devices Directive European Diagnostic Manufacturers Association Karen Howes Director Regulatory Affairs EDMA Labelling and packaging compliance for medical devices and IVDs Tuesday 25 th September 2007
2 Summary Presentation in 2 parts 1. Setting the scene for IVD labelling Karen Howes 2. Instructions for use (IFU) How to provide them to Users? Benny Ons
3 Overview Legislation on labelling IVD directive Other EU directives Country Legislation Labelling and Translation challenges IVD Device label strategies Providing IFU for professional users
4 Legislation on labelling + Country specific legislation Directive 98/79/EC on in-vitro diagnostic medical devices + Other EU legislation
5 Legislation on labelling Directive 98/79/EC on in-vitro diagnostic medical devices
6 What is an in vitro diagnostic medical device? Definition 98/79/EC 'in vitro diagnostic medical device` means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: - concerning a physiological or pathological state, or - concerning a congenital abnormality, or - to determine the safety and compatibility with potential recipients, or - to monitor therapeutic measures. Specimen receptacles are considered to be in vitro diagnostic medical devices. 'Specimen receptacles` are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
7 Labelling Requirements for IVDs IVD Directive 98/79/EC Annex I Section B.8 Labelling Requirements 8.1 This information comprises the data on the label and in the instructions for use. Instructions for use must accompany or be included in the packaging of one or more devices. No IFU needed in duly justified reasons 8.2 Symbols format and color must conform to harmonized standards additional symbols are allowed. 8.3 Hazardous labelling 8.4 Requirements for the label 8.5 If no obvious intended use clearly to be stated in the IFU 8.6 Batch number identification for devices and components 8.7 Requirements for the IFU
8 Labelling requirements of IVDs For Radioactivity Directive 96/29/EURATOM For Hazardous substances Directives on Dangerous substances 67/548/EEC and Dangerous preparations 1999/45/EC Future: Global Harmonised System: United Nations adopted in EU legislation in preparation for the adoption of GHS 27th of June 2007 Proposal for a Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 (COM(2007) 355 final).
9 Labelling requirements EU Waste Electrical and Electronic Equipment WEEE 2002/96/EC According to EN (not harmonized) labelling via the wheeled bin symbol. Should be present on all products placed on the market after 13 th August 2005 Labelling must also include a way to identify the producer unequivocally. The wheeled bin does NOT imply compliance with the WEEE directive
10 Country legislation - language IVD Directive 98/79/EC Article 4 para 4 Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user. Provided that safe and correct use of the device is ensured, Member States may authorise the information referred to in the first subparagraph to be in one or more other official Community language(s). In the application of this provision, Member States shall take into account the principle of proportionality and, in particular: (a) whether the information can be supplied by harmonised symbols or recognised codes or other measures; (b) the type of user anticipated for the device.
11 Labelling & Translation Challenges for the IVD Industry More and more requirements in every region of the world. Europe - IVD Directive 98/79/EC Article 4.4 Member States may require the information to be supplied pursuant to Annex I part B section 8 in their official language(s) when a device reaches the final user..
12 EU-EEA-Switzerland English: UK Ireland Dutch: Netherlands Belgium French: Belgium France Luxembourg Czech: Czech Republic Letzeburgish:Luxembourg Icelandic: Iceland* Danish: Denmark Norwegian: Norway* Swedish: Sweden Finnish: Finland Estonian: Estonia Latvian: Latvia Lithuanian: Lithuania German: Germany, Liechtenstein*, Luxembourg Austria Polish: Poland Hungarian: Hungary Portuguese: Portugal Slovene: Slovenia Spanish: Spain English/(Maltese): Malta Non-EEA countries that recognise CE-marking: Switzerland (German, French, Italian) Italian: Italy Slovak: Slovakia Greek: Greece - Cyprus Romania Romanian Bulgaria Bulgarian
13 IVD Industry Concern/Challenge What has happened with the May Require?
14 Europe, EEA and Switzerland Danish English Estonian French German Italian Polish Portuguese Spanish Slovak Swedish As of January 2007: Norwegian However delay obtained till Oct 2007 Romanian Bulgarian Lithuanian CzechItalian Slovak Hungarian Swedish Greek Spanish French German Portuguese English Estonian Polish Danish Norwegian Romanian Czech Greek Hungarian Lithuanian Note : Not applicable for self-testing devices as they need to have translated IFU in any language of the country where the product is placed on the market In vitro-diagnostik In vitro-diagnostik In In Bulgarian In In In In vitro-diagnostik Vitro Diagnostic In In In vitro-diagnostik In In In In In In Vitro Diagnostic Dagnostika In In In In In Diagnostic Vitro Diagnostika in In-Vitro-Diagnostikum Diagnostic in in In-Vitro-Diagnostikum In In vitro-diagnostik Vitro In-Vitro-Diagnostikum Diagnostico in Diagnostika In In Vitro In-Vitro-Diagnostikum In-Vitro-Diagnostikum Diagnostico Diagnostico Diagnostyki in in Diagnostika in Diagnostyki Diagnostico Diagnóstico in Diagnostyki vitro In-Vitro-Diagnostikum Diagnóstico Diagnostico Diagnostyki Diagnostic in in in in vitro vitro vitro Zdravotnícka Diagnóstico pomocka in vitro in vitro In Vitro Diagnostyki Zdravotnícka Diagnóstico In Diagnostika vitro pomocka diagnostik in In vitro Vitro in vitro Diagnostico in vitro vitro In-Vitro-Diagnostikum
15 IVD Medical Devices Labelling Usually 3 levels of labelling : I. Immediate Container II. Outer Container Device Label III. Instructions for Use
16 IVD Device Labels Test, text, text, text,text,text,text,te xt,text,text,text Test, text, text, text,text,text,text,te xt,text,text,text Test, text, text, text,text,text,text,te xt,text,text,text Test, text, text, text,text,text,text,te xt,text,text,text Test, text, text, text,text,text,text,te xt,text,text,text Test, text, text, text,text,text,text,te xt,text,text,text Test, text, text, text,text,text,text,te xt,text,text,text Test, text, text, text,text,text,text,te xt,text,text,text Test, text, text, text,text,text,text,te xt,text,text,text Address,address,address,address,address,address,address,address,add ress
17 IVD Device Labels - Strategies Include and translate only what is required (Remember Art information to be supplied pursuant to Annex I. partb. Section 8) IVD Directive Annex I, Part B, Section 8.4 lists the requirements SYMBOLS Guidance and presumed compliance can be found in EN 375 / EN 376 paragraph 4 requirements for labels» Subparagraph 4.1 Outer Container» Subparagraph 4.2 Immediate Container
18 IVD Devices IFU - Strategies Include and translate only what is required Art. 4.part 4. information as in Annex I. Part B. section 8 IVD Directive Annex I, Part B, Section 8.7 lists the requirements and presumed conformity. Guidance and presumed compliance can be found in EN375/EN376 and paragraph 5 requirements for instructions for use EN591/EN592 for instruments Future ISO standard in preperation on information supplied by the manufacturer(labelling) ISO includes reagents, instruments, professional use and self test.
19 IVD Medical Devices 2 Categories ) I. Devices for self-testing (lay persons as users) II. Devices for professional users
20 IVD Devices for self-testing Taking into account the lay person profile, everybody agrees there is a clear need : to translate Instructions For Use (IFU) into the official language(s) of the Member State. to provide a paper IFU together with each device. And it is a requirement to do so
21 IVD Devices for professional users Slovak Greek Spanish Portuguese Italian Czech Lithuanian French Polish Swedish Danish Estonian German Hungarian