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.
Consumer goods
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.
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.
Post-market surveillance under the MDR: New requirements
Post-market surveillance requirements are strengthened under new EU medical device regulation 2017/745. Find out what implications it has for your device.
Selling Cosmetics in Portugal
Non-EU Manufacturers and their EU importers have to meet specific requirements to sell Cosmetic Products in Portugal in the context of Market Surveillance activities at Customs. Read more about which requirements are necessary.
Merger of Belgian IVD & MD authorities
Belgian medical and in-vitro diagnostic competent authorities merged in September 2017 for increased surveillance and traceability in devices on the EU market.
The new CE marking process for the Low Voltage Equipment
The new European Low Voltage Directive (LVD 2014/35/EU) outlines a new CE marking process for equipment on or to be introduced to the EU market.