The new EU Pressure Equipment Directive (2014/68/EU) will come into effect from July 2016. Talk to Obelis about what implications it may have for your product.
Industrial and mechanical
European Commission Publishes New Guidelines on PPE Directive
EC publish new guidelines on PPE directive 89/686/EEC with the aim of levelling playing field for manufacturers seeking to comply with the directive.
The Rapid Alert System (RAPEX) is an EU-wide vigilance platform for general products. Learn more about what it is and what it does with Obelis.
European Court of Justice to Clarify Liability for Medical Device
The European Court of Justice, by request of Germany's Federal Supreme Court, will clarify the liability of notified bodies in relation to medical devices.
Eu Council agrees on a General Approach for Medical Devices and IVDs Regulations
The Council of the European Union has agreed on a general approach to new medical and in-vitro diagnostic device regulations to be finalized by the end of 2015.
Exporting to Europe – “Selling” is not Complying
In many cases it is possible for some products to have found their way onto the European Market without having undergone the proper Compliance screening processes or having been awarded an official CE Marking. In these types of cases, manufacturers may well feel that there is no real pull factor to encourage them to seek CE certification and that the onus to request information on such issues falls outside the realm of their responsibility.
What are the New Approach Directives?
The New Approach Directives are a series of legislative requirements that ensure product safety within the EU market across a range of products and devices.
Obelis Cosmetics, Exhibiting @ Cosmoprof Asia
Representatives from Obelis' European Responsible Person Center and EU regulatory team will be attending Cosmoprof Asia from November 12-14, 2014.
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.
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.