Find out what implications EU cosmetics regulations have for the use of heavy metals (zinc, tin, lead, arsenic, cobalt, mercury, etc.) in cosmetic products.
Consumer goods
Game Plan for Upgrading Compliance under Medical Device Regulation 2017/745
Since the introduction of EU Medical Device Regulation 2017/745, manufacturers have been rushing to prepare for it taking full effect on 25th May 2020. The best advice is to start getting ready for the transition now to ensure a smooth process with no negative effects. The first step in getting ready for MDR 2017/745 is understanding what it is and what requirements it has for manufacturers of medical devices. With that in mind, we put some information together to help clear the process up!
Critical ALERT (!) – EU Official Notice on BREXIT
EU Commission issued an official notice to cosmetics product manufacturers in run up to Brexit. Key items include labelling, notification, and information file.
EU Commission lowers Chromium VI in toy materials
The European Commission's Toy Safety Directive has lowered limits for Chromium VI in scraped-off toy materials (paints, wood, textiles) to 0.052 mg/kg.
Team-NB position paper on “Points to add to contracts between Manufacturers and notified bodies”
Team-NB publish template of clauses to be included in contracts between manufacturers and notified bodies, particularly those using older CE certification.
CAMD and MDR/IVDR transitional provisions
CAMD aim to provide guidance on transitional provisions for manufacturers of medical devices and in-vitro devices under the new EU regulations.
Proposal of “Goods Package” to improve compliance of products on the EU Market
The EU Commission has proposed a new regulation on compliance and enforcement to create a fairer internal market and cooperation across member states.
The impact of the new MDR and IVDR Regulations on Notified Bodies
The new MDR (2017/745) and IVDR (2017/746) will replace the EU’s current Medical Device Directive (MDD) (93/42/EEC) and In Vitro Diagnostics Directive (IVDD) (98/79/EC) to establish a more robust EU legislative framework and ensure better protection of public health and patient safety.
Phthalates found in toys on the EU market
A recent ECHA study has found that a high number of toys on the EU market contain chemicals (DEHP, DEP, BBP) restricted by the European Union.
Clinical Evaluation for medical devices (many more requirements under MDR)
Learn about the changes introduced for clinical evaluations under EU medical device regulation 2017/745. Re-classification, comparative evaluations and more.