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Latest updates
09 April 2021
Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
09 April 2021
Updated Implementation Rolling Plan - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
01 April 2021
The expert panels in the field of medical devices now accept submissions from notified bodies for the Clinical Evaluation Consultation Procedure
23 March 2021
Infographic - Is your software a Medical Device?
15 March 2021
Guidance on state of the art of COVID-19 rapid antibody tests
15 March 2021
Questions and Answers on Custom-Made Devices
26 February 2021
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
24 February 2021
COVID-19 tests: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19
18 January 2021
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
11 January 2021
Covid-19: Commission Notice on audits to be performed by notified bodies
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Wed, 03/31/2021
Komisija podpira preglednost z novo uredbo o živilih
Latest updates
Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
Released
09 April 2021
Updated Implementation Rolling Plan - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Released
09 April 2021
The expert panels in the field of medical devices now accept submissions from notified bodies for the Clinical Evaluation Consultation Procedure
Released
01 April 2021
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Highlights
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
Commission Notice on notified bodies’ audits performed during Covid-19 exceptional circumstances
Commission Implementing Regulation (EU) 2020/1207 laying down rules as regards common specifications for the reprocessing of single-use devices
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