IVDR: Harmonised standards for QMS and risk management
May 26, 2022, is an important date for all stakeholders of the IVD sector. The…
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May 26, 2022, is an important date for all stakeholders of the IVD sector. The…
The new Regulation on in vitro medical devices (IVDR) will start to apply on May…
The NANDO database has a new Notified Body under the IVDR! 3EC International a.s. is the…
On April 27, 2022, the Directorate-General for Health and Food Safety published a new Report…
The Dutch Regulation of the Minister for Medical Care (cited as the Dutch Medical Devices…
The MDCG has released new guidance on borderline cases between medical devices and medicinal products under the Medical…
Customs Union The Ankara Agreement outlines the cooperation between Turkey and the European Economic Community…
Notified Bodies and Certificates The European Commission has released updated documents on the technical documentation…
The European Commission published its update from March of the Joint implementation and preparedness Plan…
The NANDO database newly listed 28 Notified Bodies under the MDR! SLOVENIAN INSTITUTE OF QUALITY…
The MDCG has updated its Guidance on the Summary of Safety and Clinical Performance (SSCP),…
Austria has implemented Regulation 2017/745 through the Medical Devices Act in force from 30 June…
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