Ochrana verejného zdravia v EÚ

Improving health systems

Starostlivosť o zdravie

Medical devices

Substances of human origin

Krv, tkanivá a orgány

Farmaceutické výrobky

Opatrenia proti chorobám

Hodnotenie rizika

Vedecké výbory

Endocrine disruptors

Endocrine disruptors

Biocides

Biocides

Nové

26 Február 2021

Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
24 Február 2021

COVID-19 tests: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19
18 Január 2021

Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
11 Január 2021

Covid-19: Commission Notice on audits to be performed by notified bodies
18 December 2020

Updated Implementation Rolling Plan - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
18 December 2020

Updated - Ongoing guidance development within MDCG Subgroups
15 December 2020

MDCG 2020-18 - MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
02 December 2020

MDCG 2020-17 - Questions and Answers related to MDCG 2020-4: “Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”
01 December 2020

The EUDAMED Actor module is in production. On 1st December 2020 the European Commission has made available the Actor registration module to Member States and economic operators
13 November 2020

Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

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