MDCG 2019-14 Explanatory note on MDR codes
Posts published in “European Commission”
MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the…
EU Commissioner for Health: MDR’s May 2020 Deadline Won’t Change
IFA UDI HRI & AIDC Formats IFA Basic UDI-DI ICCBBA Basic UDI-DI ICCBBA UDI HRI & AIDC Formats HIBCC Basic UDI-DI HIBCC UDI HRI &…
MDR EUDAMED-UDI- Data Dictionary V5.0
EU – EUDAMED State Of Play : Open Letter From The CAMD Executive Group
Multilingual Legend for the Summary list of harmonised standards
CORRIGENDUM to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC)…
Why are potential dangerous phthalates allowed in medical devices, and who decides if their use is warranted?
Observation 1 – This is the third installment of my series on medical device clinical evaluation. I suggest reading the first part at (http://www.medicaldevice.expert/) to…