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European Commission Publishes New Guidelines on PPE Directive
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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
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Final Opinion on the Safety of Medical Devices containing DEHP (phthalate)
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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 [...]

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Steps to obtain CE Marking

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

In order to issue a Quote, the classification of your product according to EU Regulation is imperative (!). 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 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 *

Email *

Phone *

Fax

Company & Product Information

Your Website URL

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.

CE Marking

Construction Products Directive

Electromagnetic Compatibility

Environmental

General Product Safety

Low Voltage Electrical Equipment

Machinery Directive

Personal Protective Equipment

Pressure Equipment Directive

Radio and Telecommunications Terminal Equipment Directive

Toy Safety Directive

Additional Information

Regulatory Advisor

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