Latest News on Consumer Goods and Compliance

Potential Impact of Brexit over Authorized Representatives

The UK has officially started the withdrawal procedure of their EU Membership by delivering the formal letter invoking Article 50 TEU on the 29th of March 2017. Complex negotiations will follow with a tight deadline of two years to settle various regulatory issues. What are the possible consequences involved for the European Authorized Representatives (EAR) ?
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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.

A professional uses an ultrasound machine

Belgian Medical Competent Authority abolishes submission taxes

Belgian medical competent authorities abolish submissions taxes to help ease manufacturers' entry to the European market.

Not only UVA and UVB

The use of screens, smartphones and tablets expose the skin to blue light, that can lead to health issues. Find out how cosmetics can protect from blue and infrared light.

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.

Israel aligns with European cosmetics law

The Israeli Ministry of Health has announced new drafts of regulations called “Pharmacists’ Regulations (Cosmetics)” that mirror the European Regulation on cosmetics.

ISO 13485:2016 strengthens the control of suppliers in Medical Device Industry

ISO 13485:2016 aims to harmonise quality system requirements and ensure a higher degree of compliance with regulations amongst suppliers of medical devices.