Throughout the many changes the EU Medical Device Regulations 2017/745 and 2017/746 will bring, one equally important is the introduction of a device traceability system based on Unique Device Identification, most commonly mentioned as UDI, within the healthcare supply chain. Read more about it here.
The second corrigendum to Regulation (EU) 2017/745 on medical devices has brought a change in the wording of certain part of articles 78(8), 120(3), 120(4), 120(8) and 122; but what does it imply for the concerned economic operators?
A large-scale inspection campaign on dental implants, carried out by the French Ministry of Health (ANSM) Inspection Department, took place in 16 manufacturers’ and 16 distributors’ facilities. Read on this topic here.
What are the next steps regarding the Brexit? Find out about the relevant information on this topic.
Medical devices, Brexit, CE marking, CE Certificates, European Market
“ISO 20916 – In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice” was published in May 2019.
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
European market harmonized standards, importance of ce marking, Ce marking, ce marking European market
What do the New Guidelines from the International Medical Device Regulators Forum include? Read on the clinical evidence, clinical investigation and clinical evaluation.
Companies are requested to ensure sufficient stock and continuity of supply during the transition. Start your compliance roadmap with Obelis.
The Spanish Agency of Medicines and Medical Devices (AEMPS) has published a Checklist to verify the Brexit readiness of companies based in Spain in the sectors…