Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)
News

Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of Septemb [...]

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…) [...]

CE Marking Services from Obelis

Obelis Services

in CE Marking Services from Obelis

Obelis European Authorized Representative Center provides ISO certified services for the successful introduction of medical devices within the European territory, in accordance to the Medical Device Directive 93/42/EEC and its amendment 2007/47/ECIn-Vitro Diagnostics Directive 98/79/EC and Active Implantable Medical Devices Directive 90/385/EEC.

Those services include, but are not limited to, the following:

Our services are backed by over 25 years of experience with CE Marking consultation and European Authorized Representative services. We are located within walking distance of the European Commission and maintain close relations with the EU Administration.


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European Authorized Representative Services

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Our professional European Authorized Representative services aim to ensure compliance with MDD 93/42/ECCIVDD 98/79/EC and AIMDD 90/385/EEC:

“Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate for this device a single authorized representative in the European Union”. -Amendment 42 Article 2, Point 7 - Article 14, paragraph 2, subparagraph 1 

Our services in this area include, but are not limited to:


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EU National Registrations

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Services for Device Registration in France

Services for Device Registration in Greece

Services for Device Registration in Italy

Services for Device Registration in Latvia

Services for Device Registration in Portugal


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Free Sales Certificate Services

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According to the European Medical Device Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC, CE marked and properly registered devices in all 27 EU member states and 4 EFTA countries have free access to the EU market (according to Article 14 MDD 93/42/EEC as amended by the 2007/47/EC and Article 10 IVDD 98/79/EC). Thus, once your device is properly CE marked, it is allowed to circulate and be sold throughout the European Union.

However, the CE Marking only enables penetration to the European market and does not enable the device to be placed on other global markets.

Due to the high standards of health and safety required by the CE Marking, customers in non-EU countries request a Free Sales Certificate from the manufacturer to demonstrate the device meets the various safety and health requirements specified by the CE Marking. The Certificate will enable the device to penetrate the market of the relevant country and be freely sold to the public (presuming all local requirements are also met).

As the manufacturer is not within the European territory and cannot communicate with the Authorities, this certificate can only be obtained through the manufacturer’s legal entity in Europe, the Authorized Representative.

In order to get the Free Sales Certificate for MDD and IVD devices, two conditions need to be met:

  1. The device must bear the CE Marking
  2. The manufacturer has appointed a European Authorized Representative for his device

Additionally:

If the device(s) are CE marked, but not properly notified/registered with the European Authorities by the appointed European Authorized Representative (as required by Law for MDD Class I and IVD devices), the CE Marking is NOT valid and therefore the Free Sales Certificate cannot be issued.

To receive a Free Sales Certificate, you will be required to present your Authorized Representative with the following:

  • Information about the device
  • Name and form of the device
  • Classification (according to EU regulation)
  • Composition and description
  • CE Certificate
  • Information about the manufacturer
  • Name and contact details
  • Production Site
  • Contact details for Notified Body

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Advisory Services

in CE Marking Services from Obelis

Obelis aims to provide you with full solutions for the introduction of your medical devices to the European market. Among other things, our team of experts will guide you on:

  • Permitted claims and regulatory advice
  • QMS implementation
  • Product safety consultancy
  • Product testing and certification services
  • Identification of proper regulation
  • Identification of EU harmonized standards
  • Post market surveillance assistance
  • Regulatory advice and updates

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Technical File Services

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Obelis Technical File services include the review and gap analysis of an existing Technical File, as well as the creation of a complete and compliant Technical File.

Our Technical File Review/Creation services include, but are not limited to, the following:

  1. Device Classification.
  2. Identification of applicable standards.
  3. Risk management report and gap analysis.
  4. Clinical evidence report and gap analysis.
  5. Safety and biocompatibility.
  6. Guidance on suppliers/subcontractors agreements.
  7. Templates and checklists.
  8. Labeling & Packaging.

For further information about Technical Files, click here: Technical File Compliance.


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Notified Bodies Selection Services

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Our Notified Body Selection services include:

  • Device Classification.
  • Identification of conformity assessment options.
  • Notified Body offer analysis.
  • Notified Body negotiation.

For further information about Notified Bodies for Medical Devices, click here: Notified Bodies Compliance.


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Additional Services

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Additionally, we also provide the following services:


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Global Services

in CE Marking Services from Obelis

At Obelis, our mission is to provide our clients with the finest quality services and personalized solutions to the complex regulatory requirements throughout the world. Therefore, we have developed a wide range of solutions to provide you with support in over 20 markets worldwide. With Obelis, you get:

  • Access to an International Network
  • Regulatory Solutions
  • International representation

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