Notification of a Body in the framework of a technical harmonization directive – CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
Posts published in March 2020
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
State of play of joint assessments of Notified Bodies in the medical device sector
FDA issues “Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic”
Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
MDCG 2019-8 v2 – Guidance document – Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of…
MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or…