EU Council report shows progress on proposed new medical device and in-vitro diagnostic device regulations to replace previous European directives.
Formula Verification Service
European regulatory and compliance experts Obelis announce new formula verification service for manufacturers starting the EU compliance process.
Annex II of Toy Safety Directive amended by EC!
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.
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.
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 EC Directive on Radio & Telecommunications
EU introduces new radio and telecommunications directive 2014/53/EU to replace current legislation. The directive will enter into force in June 2016.
EC proposes NEW Regulation on Personal Protective Equipments
The EC proposed new personal protective equipment (PPE) regulation to replace current EU legislature and harmonize Europe-wide standards and requirements.
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.
More Supervision on Notified Bodies by NEW 920/2013 Regulation
New EU implementing regulation 920/2013 to set more stringent requirements for the designation and supervision of Notified Bodies within Europe.