If you wish to have more information about the new Nomenclature, Obelis Experts will assist you in ensuring compliance of your IVD medical devices.
Medical devices and healthcare auto
The European Medical Device Nomenclature (EMDN): Background and Generalities
The CND classifies medical devices in three different levels – Category (first level), Group (second level) and Type (third level) – following an alphanumeric structure.
Spanish Agency on labelling medical devices in case of Brexit
Advice and guidance from the Spanish regulatory experts on how to handle medical device labelling under Brexit. Assigning an EAR, notification, and more.
The European Commission has published a FAQ document on UDI
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.
Second Corrigendum to the MDR: A Christmas gift for manufacturers
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?
ISO 20916 – IVDs – Clinical performance studies using specimens from human subjects – Good study practice
“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.
Quality controls of medical devices emitting ionizing radiation on the French market
European market harmonized standards, importance of ce marking, Ce marking, ce marking European market
New guidelines on clinical evidence, clinical investigation and clinical evaluation
What do the New Guidelines from the International Medical Device Regulators Forum include? Read on the clinical evidence, clinical investigation and clinical evaluation.
Spain is ready for Brexit: new checklist for Medical Devices and Cosmetics
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…
New EU Regulation on Market Surveillance and Compliance of Products
The new Regulation sets out an obligation for economic operators to cooperate with the market surveillance authorities and establishes a framework for the control of products entering the Union market.