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?
Medical devices and healthcare auto
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.
MHRA Guidance on Assistive Technology: medical device or not?
Products that assist and support individuals with disabilities, restricted mobility or other conditions to perform functions that would be difficult to perform without such products are known as ‘Assistive Technology’.Classifying these products is not an easy task as they might be a medical device or an ‘aid for daily living’. Read more about it.
MDR in few words
A brief overview of the best path for ensuring full compliance with MDR 2017/745 and the implications it has for medical device manufacturers in Europe.
How to understand Basic UDI-DI and UDI
EU regulatory experts explain the Unique Device Identification (UDI) system and what it means for you under EU Medical Device Regulations 2017/745 and 2017/746.
EU – USA Cooperation in Medical Devices
Europe and US set to work together to reduce barriers and increase trade in medical products. Cooperation could reduce manufacturing costs and improve controls.