Kansanterveystyö EU:ssa

Improving health systems

Terveyden edistäminen

Medical devices

Substances of human origin

Veri, kudokset ja elimet

Lääkkeet

Tautien torjunta

Riskinarviointi

Tieteelliset komiteat

Endocrine disruptors

Endocrine disruptors

Biocides

Biocides

Tuoreimmat päivitykset

21 lokakuuta 2021

MDCG 2021-25 - Application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
21 lokakuuta 2021

MDCG 2021-26 - Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
14 lokakuuta 2021

COM(2021)627 - Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices
14 lokakuuta 2021

Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation
14 lokakuuta 2021

Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation
04 lokakuuta 2021

MDCG 2021-24 - Guidance on classification of medical devices
04 lokakuuta 2021

The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basis
04 lokakuuta 2021

MDCG 2019-6 Rev.3 - Questions and answers: Requirements relating to notified bodies
03 syyskuuta 2021

The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure
20 elokuuta 2021

MDCG 2021-23 - Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

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