MEDDEV 2.7/1 – new guidelines on clinical evaluations
News

On the 29th of June 2016, the European Commission released a new version of MEDDEV 2.7/1, entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and [...]

EU to release NEW Medical Device Regulations!
News

In June 2016, the European Parliament released the consolidated texts of the new EU Regulation Proposals on Medical Devices and In-Vitro Diagnostics Devices. The texts, published on the European Par [...]

New Medical Devices and In-Vitro Diagnostic Regulations – Status of the Ongoing Discussions
News

The approval of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices will be postponed to 2016. (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 [...]

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

The Obelis European Authorized Representative Center (O.E.A.R.C.) has been established in Brussels since 1988. Located at the heart of the EU, we provide European Authorized Representative (EC REP) and CE marking advisory services to manufacturers all over the world in accordance with European Directives and Regulations.

Backed by our ISO 9001:2008 & ISO 13485:2003 certification, our high quality compliance solutions include, but are by no means limited to, the following:

  • Classification
  • Identification of EU standards
  • Technical Documentation review
  • Product Notification and Registration to national EU Authorities
  • Labelling Compliance
  • GMDN Code Verification
  • Free Sales Certificates
  • Trade Mark Submissions

With a unique expertise on medical devices and in-vitro diagnosis medical devices, our expert teams will assist you in introducing and/or maintaining the circulation of your product (s) within the EU market. Our consultants will guide you through the regulatory maze and various medical device directives to ensure access to the EU market for you and your devices.

Contact our regulatory consultants today to let us help you meet your requirements.

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