As squishy and slime toys are becoming increasingly popular among children, many EU member states have been strengthening inspections for harmful chemicals in their composition.
News
Type-approval for vehicles: Revised General Safety Regulation enters into force
As of July 2022, the new rules require all vehicle models introduced on the European market to be equipped with advanced safety features.
SCCS final opinion on UV filter S87 and hair dye C183
Introducing cosmetic products, requirements for cosmetic products on eu market, obligations for cosmetic products on eu market, Compliance process
AEMPS: Quarterly report of the Spanish Authorities about cosmetic products – July to September 2019
The Spanish Authorities have published their quarterly report about cosmetic products vigilance and control and some points are to be highlighted.
Read more about it.
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?
Inspection of dental implants by the French Authority
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.
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