Upon completion of the notification process of “Class I medical devices” product family, the Manufacturer can receive a Certificate of CE registration (195,00 € per original copy) authenticated by Obelis CEO and the Brussels Enterprise Commerce and Industry – BECI (Brussels Chamber of Commerce). The Certificate of CE registration will be numbered and dated, certifying and providing the evidence that according to the European Council Directive 93/42/EEC and 2007/42/EC, Obelis performed all notification duties and responsibilities as the European Authorized Representative (EC REP) of the manufacturer; that the manufacturer has provided Obelis s.a. (O.E.A.R.C.) with all the appropriate declarations as per the European Council Directive 93/42/EEC – article 14 requirements, including the EC Declaration of Conformity (according to Annex VII) confirming that the manufacturer’s medical devices, are fulfilling the applicable requirements of the European Council Directive 93/42/EEC and 2007/42/EC; and that the manufacturer is therefore allowed to sell his products in the EU territory from the date of the certificate provided that he will continue to comply with the here above mentioned requirements.
The Certificate of CE notification is often the only evidence that the notification for the MDD has been performed in conformance with the MD Directive 93/42/EEC and 2007/42/EC, as usually EU member states do not have the obligation to provide manufacturers/distributors with acknowledgement of receipt, or they might do so but very late in the process, or they might do so by simply stating “I received”.
Therefore, it is recommended to have such a Certificate:
- for your own sake knowing all the necessary steps have been taken by the manufacturer to comply with the EU regulation
- for anyone (customer, customs, competent authorities from other countries,…) requesting it, willing to know whether the product has been notified and complies with the EU regulation
- to know the precise date of notification allowing you to sell in the mentioned country
The benefits of the certificate can help businesses jump into the European market successfully and quickly.
Please contact firstname.lastname@example.org for more information.