www.adapt-localization.com medical device localisation michael kemmann adapt localization services

www.adapt-localization.com

Medical Device Localisation

Michael Kemmann

ADAPT Localization Services


1

Medical Localisation

The Regulatory Environment


"Medical Localisation" – What's Different?

Safety requirements Regulatory requirements Formalised environment Specific workflows


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)


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 )


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)."


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)


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


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


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 %)


2

Medical Localisation

Challenges And Solutions


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


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


Specific Challenges – Review Process

Review:Often delays projectCan sometimes introduce problems

Reviewers: Mostly Marketing or Technical Support staffOften volunteering, without assigned time budget for

reviewUsually no experience with translation technology and

localisation workflowsTendency to focus on less important issues


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)


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


Thank You!

Michael Kemmann

ADAPT Localization Services

Clemens-August-Str. 16-18

53115 Bonn, [email protected]

www.adapt-localization.com medical device localisation michael kemmann adapt localization services

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