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Medical Device Testing and Auditing
available in the following languages:
EN
DE
IT
or select your TÜV Rheinland region / country website:
Albania
Algeria
Argentina
Armenia
Australia
Austria
Bahrain
Bangladesh
Belgium
Bolivia
Bosnia and Herzegovina
Brazil
Bulgaria
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Canada
Chile
China
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Czech Republic
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Germany
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Inform yourself about the latest changes and news of the regulation 2022/112.
Official Journal of the European Union (L19)
Regulation (EU) 2022/112 as regards transitional provisions for certain in vitro diagnostic medical
Questionnaires and application documents for certification
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General documents
(Significant) Change Notification - Product Assessment
(Significant) Change Notification - QMS Assessment
Questions for Quoting – QMS Module
Checklist for Client Reporting of Incidents
MDR
Questions for Quoting – MDR Module
Guidance for MDR Technical Documentation Submissions
Annex A Checklist for MDR Technical Documentation Submissions
IVDR
Questions for Quoting - IVDR Module
Guidance for IVDR Technical Documentation Submissions
Annex A Checklist for IVDR Technical Documentation Submissions
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