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Here you will find our current newsletter as well as important information on changes and news regarding the regulations. Furthermore, we provide you with all relevant documents that will help you in the preparation of questionnaires and offers for MDR and IVDR.

Medical Devices | Regulatory Newsletter 05/2023

Latest News

Inform yourself about the latest changes and news of the regulation 2022/112

Official Journal of the European Union (L19)

Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices

Questionnaires and application documents for certification