Updates to the EU Toy Safety Directive provide specific limits on TCEP, TCCP, and TDCP chemical in toys placed on the EU market. Read more with Obelis.
News
Irish Authorities restructure
From July 2014, the national Irish medical and cosmetics regulator, Health Products Regulatory Authority, will become known as the Irish Medicines Board.
Italy Decree on online registration of IVDs!
Italy enacts decree requiring in-vitro diagnostics device manufacturers with devices on the Italian market to register products with health ministry database.
CPNP upload
Read more about the Cosmetics Products Notification Portal created under EU cosmetics regulation 1223/2009/EC to replace national registration and notification.
Legal Challenges at time of Non-Renewal of a CE certificate
More information on the legal challenges and difficulties that may result from non-renewal of CE certification for products place on the European market.
New version of the Blue Guide 2014. What is new?
EC publishes revised Blue Guide on implementation of product rules to reflect modernization and harmonization of legislative framework for product marketing.
New Electromagnetic Compatibility Directive 2014/30/EU
EU to introduce new electromagnetic compatibility directive to regulate compatibility of devices and ensure reduced electrical disturbance and consumer risk.
New IEC 60601-1-2: 4th Edition for Medical Electrical Equipment
International Electrotechnical Commission introduce 4th edition of IEC 6061-1-2:2004 to include technical revisions on risk analysis and immunity requirements.
ISO 9001:2015 – What You Need to Know
Find out more about ISO 9001:2015 – why it is coming into effect, what impact it may have for your products, transition periods, and how to prepare for it.
EC Guidelines on Product Information File
New EC guidelines detail relevant data to be considered as minimum when detailing a Product Information File for cosmetic products on the EU market.