European Commission Publishes New Guidelines on PPE Directive
News

On 19 October 2015, the European Commission published new Guidelines on the application of Personal Protective Equipment Directive 89/686/EEC (PPE Directive). (more…) [...]

Common Approach on the Medical Devices Legislative Package
News

On October 5, 2015, the Ministers of the EU countries agreed, after almost three years of discussions, on a general approach on the medical devices legislative package. This agreement is a major step [...]

New Harmonized Standards on R&TTE
News

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, whi [...]

Final Opinion on the Safety of Medical Devices containing DEHP (phthalate)
News

After months of public consultation, The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has now published the final Opinion on the safety of medical devices containing DE [...]

IMDRF proposes QMS Principles for Software as a Medical Device
News

In April 2015, the International Medical Device Regulators Forum (IMDRF) released a new guidance document on the application of Quality Management Systems (QMS) for software as a Medical Device (SaMD) [...]

Button_EAR_cem
Button_Compliance_cem
Button_Services_cem

 

Obelis European Authorized Representative Center (O.E.A.R.C.)

Obelis European Authorized Representative Center (O.E.A.R.C.), established in Brussels (Belgium) since 1988, provides European Authorized Representative (EC REP), “EU Responsible Person” & CE Marking advisory services to manufacturers worldwide (EU & Non-EU), all in accordance with European Directives & Regulations.

Our high quality compliance solutions, proven by our ISO 9001:2008 & ISO 13485:2003 certification, include Classification, identification of EU standards, Technical Documentation review, Authorized Representative & EU Responsible Person, Product Notification & Product Registration to national EU Authorities, Labelling Compliance, GMDN Code Verification, Free Sales Certificates, Trade Mark submissions and many more.

While still retaining a unique expertise on medical devices, in-vitro diagnosis medical devices & cosmetics, our team of experts will assists you in introducing or maintaining your product(s) circulation within the EU Market and guide you through the regulatory maze of product safety and requirements also for machinery, personal protective equipment, pressure equipment, radio and telecommunication equipment, electrical equipment, low voltage equipments, toys and other consumer goods.

Contact us today and let us help you meet your requirements.

 

Was it useful? Share it!