The European Commission asked the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) for a scientific opinion to assess the safety of Metal-on-Metal (MoM) joint replacements with a particular focus on hip implants. The final opinion has been adopted on September 24th 2014.The opinion aims to assess whether
A new Regulation (EU 207/2012) on electronic instructions for use of medical devices has been recently adopted by the European Commission and it will come into full force starting 1st of Marc 2013.Apart from the CE marking affix requirements and the designation of a European Authorized Representative (EAR)
On April 29th 2012, France published in its official journal about the creation of a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), aimed to replace entirely its current regulatory agency, Afssaps, within a few months.The MSNA will cover the mission, the rights
In 2011 the EU Heads of State and Government called on the European Commission to bring together all of the previous EU’s research and innovation funding under a single common strategic framework. The Commission launched a wide-ranging consultation involving all key stakeholders which has led to Horizon 2020.The
On the 5th April 2016, the European Commission published an updated version of “The Blue Guide on the Implementation of EU Product Rules”. The document, commonly referred to as the “Blue Guide”, sets out guidelines on introducing products to the EU market. It serves as a reference point for the
Every Personal Protective Manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis European Authorized Representative for steps tailored to your company. It is important to select your European Authorized Representative before choosing a Notified Body; particularly before categorizing
Obtaining the CE Marking provides a great strategic advantage for any manufacturer! – This is true whether your business is one of an Original Equipment Manufacturers (OEM) or anOriginal Brand Labeler (OBL).Conclusion:If you are an OEM manufacturer – Obtain your own CE Marking today!What is the difference between OEM
What is the objective?The utmost aims of the WEEE Directive are to reduce the amount of waste electrical and electronic equipment that piles up in landfills and to enhance a more efficient environmental protection. The Official Journal of the European Parliament has published the NEW WEEE Directive 2012/19/
New references of harmonised standards published: personal protective equipment, radio equipment, machinery, ATEX, construction products, eco-design and energy labelling, pressure equipment and simple pressure vessels:Harmonised standards represent a useful tool to make products and services compliant with the relevant EU legislation. They have been introduced in several fields by
On 19th July 2016 the new Pressure Equipment Directive 2014/68/EU will come into force, and replace the old Pressure Equipment Directive 97/23/EC.The industrial sector of Pressure Equipment concerns a wide range of products, from consumer products like fire extinguishers and pressure cookers to huge and
The Low Voltage Directive (LVD) 2006/95/EC is one of the oldest Single Market Directives. It covers the conformity assessment procedure applied to equipment before placing on the Market and Essential Health and Safety Requirements which such equipment must meet either directly or by means of harmonised standards.The
In July 2015, the European Commission published an updated list of harmonized standards for Radio and Telecommunication Terminal Equipment (R&TTE). This adds new relevant harmonized standards, while modifying some of the already existing ones.Background and potential impactThe R&TTE Directive covers ‘radio equipment’ and ‘telecommunication terminal
