1. www.adapt-localization.com Medical Device Localisation Michael Kemmann ADAPT Localization Services

2. www.adapt-localization.com 1 Medical Localisation The Regulatory Environment

3. www.adapt-localization.com "Medical Localisation" – What's Different?  Safety requirements  Regulatory requirements  Formalised environment  Specific workflows

4. www.adapt-localization.com EU – Regulatory Requirements: CE Marking  Declaration by the manufacturer that the product meets all the requirements of the relevant (national) legislation implementing certain EU Directives  Gives companies easier access into the European market to sell their products without adaptation or rechecking  "CE" stands for "Conformité Européenne" and indicates a manufacturer's declaration that the product meets the requirements of the applicable EU Directive(s)

5. www.adapt-localization.com EU – Regulatory Requirements: Directives Directives applicable for the medical device and in vitro diagnostic industries:  Directive Concerning Active Implantable Medical Devices (AIMD Directive, 90/385/EEC)  Directive Concerning Medical Devices (MD Directive, 93/42/EEC)  Directive Concerning In Vitro Diagnostic Devices (IVD Directive, 98/79/EC )

6. www.adapt-localization.com Requirements of the Directives Concerning Languages  AIMD Directive: "When a device is put into service, Member States may require the information described... to be in their national language(s)."  MD Directive: "Member States may require the information… to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use."  IVD Directive: "Member States may require the information to be supplied… 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)."

7. www.adapt-localization.com Directives And National Law  Actual language requirements are defined per country, and by individual national laws, not EU law  Different levels of language requirements for different types of information: e.g., safety-related / non safety-related information, for patient use / for professional use  Different levels of enforcement: some countries allow for "negotiated" solutions  New EU members comply with the directives and have implemented their language requirements into national law (partially even before the "old" member states did)

8. www.adapt-localization.com European Union – Member States  15 members before May 1st, 2004: Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden  10 new members since May 1st, 2004: Cyprus (Greek part only), Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia  Potential candidates (2007 or later): Bulgaria, Romania, Turkey, maybe Croatia

9. www.adapt-localization.com European Union – Official Languages  20 official EU languages since May 1st, 2004: Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish Portuguese, Slovak, Slovene, Spanish, Swedish

10. www.adapt-localization.com EU Member States – Other Languages  National official languages which are not EU languages: Frisian (Netherlands), Gaelic (Ireland), Mirandese (Portugal)  Local languages, sometimes with special status: e.g. Welsh and Scottish in Britain, Catalan, Galician or Basque in Spain, Moravian in Czech Republic  Immigrant or ethnic minority languages, e.g. Turkish, Arabic, Bosnian, Croatian, Serb, Roma  Large Russian population in some of the new member states: Latvia (29.6 %), Estonia (28.1 %), Lithuania (8.7 %)

11. www.adapt-localization.com 2 Medical Localisation Challenges And Solutions

12. www.adapt-localization.com Typical Workflow Enquiry & Order QA 1: Editing / Proofreading File Reconversion QA 2: In-Country Review Delivery: Final Files Reviewer Sign-Offs Certifications Wrap-Up: Invoicing Documentation / Archiving Feedback Preparation: Team Setup Terminology / Translation Memory File Preparation / Conversion Task & Information Distribution Localization: Translation Graphics Work Implementation of Changes / DTP & Graphics / QA QA 3: Final Formatted Review

13. www.adapt-localization.com Specific Challenges – Translator Selection  Scientific vs. linguistic approach  Good technical capabilities required (e.g., very specific software file formats)  Addressee awareness necessary (e.g., professional use or patient use)  Proficient and very conscientious use of language technology required

14. www.adapt-localization.com Specific Challenges – Review Process  Review:  Often delays project  Can sometimes introduce problems  Reviewers:  Mostly Marketing or Technical Support staff  Often volunteering, without assigned time budget for review  Usually no experience with translation technology and localisation workflows  Tendency to focus on less important issues

15. www.adapt-localization.com Specific Challenges – TM Usage  Nonverbal information needs to be taken into account when translating (e.g., standardised icons)  Improperly edited "Fuzzy Matches" can cause serious problems:  Figures (e.g., 0.02 / 0.002)  Abbreviations (e.g., HIV / HCM)  Measurement units (e.g., ml / µl; days / hours)

16. www.adapt-localization.com Specific Challenges – Regulated Environments  ISO 9000 / 13485 driven structures  Formalised and sometimes inflexible processes (e.g., Purchasing) not at all tailored to (translation) services  Demand for highly formal description of production (in particular QA) processes (e.g., SOPs)  Complex error / customer complaint handling procedures

17. www.adapt-localization.com Thank You! Michael Kemmann ADAPT Localization Services Clemens-August-Str. 16-18 53115 Bonn, Germany michael.kemmann@adapt-localization.com