The manufacturer shall determine the applicable standards for the product, at national, European or the international level, and then identify the appropriate conformity assessment module according to the product classification. Finally, a full “Quality System” shall be implemented, which includes post-market surveillance, vigilance and traceability, a risk analysis report and a safety assessment report.
Technical File Data & Declarations:
- “Risk Analysis report”
- “Safety Assessment”: You need to identify what kind of test your product was submitted to and test report(s).
- Complete (exhaustive) list of standards your product is currently complying with. (US, EN, ISO, others…)
- US standards certificates, ISO certificates, if any.
- A Declaration of Conformity that you have appointed a “European Authorized Representative”.
- Copy of your “Quality Manual”
- Copy of your product package insert/instructions of use: (a) please note that according to the European Directive 2001/95/EC, you should specify, very clearly, which are the possible risks your product could expose the end user to. A Warning/Caution should be clearly stated in your product package insert. Moreover, the Competent Authorities insisted that your product package insert should clearly mention the exact and safe intended use of your product and possible side effects, if any.
(b) Language requirements: The Royal Decree (Implementation of the directive in the Belgian law) on “General Product Safety” article 8, requires the manufacturer to release the product if it is an end user’s product, with all relevant labeling and package insert at least in one of the national languages (Belgium: French, Dutch or German). As language requirements are left to each EU Member State specific regulation, you should keep available labeling and package inserts in each EU Member state official language(s). Of course, we will be able to help you identifying all EU Member States specific language requirements.
- Labeling: (a) This labeling should clearly mention both manufacturer’s name and complete details (address, tel., fax, email address) and the “European Authorized Representative” complete details (address, tel., fax, email address)
(b) Language requirements: see above product package insert.
- Post Market Surveillance: Complete file (procedures, forms, etc.)
- Vigilance & Traceability: description. (Read carefully 2001/95/EC European Council Directive, chapter III, article 5)
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.
The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the market.