Team-NB Position Paper on Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745.
Posts tagged as “MDR”
Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/745 on medical devices as regards the dates of application…
Notification of a Body in the framework of a technical harmonization directive – CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
State of play of joint assessments of Notified Bodies in the medical device sector
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
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…
Czech Notified Body Yet to Apply Under MDR as Others Prep for Post-May Designations