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.
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BREXIT: What happens now?
What are the next steps regarding the Brexit? Find out about the relevant information on this topic.
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
SCCS releases a final opinion on Allergy Alert Test (AAT)
Introducing cosmetic products to European market, requirements for cosmetic products on eu market, European responsible person cosmetics
Revision of 2 restrictions under the EU Cosmetics Regulation (HEPB, TiO2[nano])
Requirements for cosmetic products on eu market, cosmetics compliance process eu market, obligations for cosmetics manufacturers Europe
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.
Several important opinions issued by the SCCS
The Scientific Committee on Consumer Safety (SCCS) recently scrutinized several ingredients, commonly used in various cosmetics products.
Why is label review one of the last steps in the compliance process?
Answering questions on the cosmetics products labelling process. When should you label your product? Find out with Obelis' EU regulatory consulting team.
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…