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…) [...]

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The Four Steps to Obtaining CE Marking

  1. Classifying your product
  2. Providing Contact Information
  3. Adding additional requests
  4. After posting your query, a response by Obelis will be sent within 12-24 hours (!)

In order to issue a quote, it is imperative that we have the classification of your product according to EU Regulation. All requirements and conformity assessment procedures, as well as the respective services of the Authorized Representative, will be defined based on the product classification.

If you are unable to classify your product, we will happily do so for you (free of charge!). In order to classify your products we will need to receive the following information (for each product):

  • Product description: a copy of a leaflet or flyer will do (a website in English can suffice as well).
  • Claimed intent of use (what do you claim the product is intended to do?)
  • Short description of the mode of operation (how is the product fulfilling its function?)

If you have already obtained a CE certificate, you can simply indicate it to us with the relevant classification of your product. It will help us to provide you with the most accurate quote for Authorized Representative services.

Remember:

Obtaining a CE certificate by a Notified Body (when applicable) helps the European Authorized Representative in fulfilling its tasks!





Contact Information

Company Name *

Company Registration #

Company Official Address

Country

Contact Person *

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Phone *

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Company & Product Information

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Company Activity

Product Description

Intent of Use

Will you place the product on the market under your name?

Relevant Directives

Check at least one directive that applies to your project. For more information on a directive visit the Legislation page.

Medical Devices

In Vitro Diagnostic Device

Active Implantable Medical Devices

Additional Information

Regulatory Advisor

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