Statement about the independence of Berlin Cert GmbH

Berlin Cert declares, on its own responsibility, that no dependencies exist within the meaning of MEDDEV 2.10/2 which would influence decisions within the scope of testing and certification activities. Independence in relation to this is regularly checked by a panel for the safeguarding of independence. This panel, consisting of leaders representing various interests, will be presented with an analysis of factors which might possibly influence independence which it will then evaluate. The result of this assessment will be checked by the designated agencies (ZLG, ZLS, DAkkS) within the framework of accreditations, appointing and monitoring audits.

Legal foundations

On a European level it was agreed that Medical Devices Guidance Document MEDDEV 2.10/2 was to be binding for the designated agencies in individual member states. In Germany, the states are responsible for this area; they have implemented this agreement through the accreditation guidelines of the ZLG. This means that the guidelines contained in this document pertaining to the independence of the agencies and staff who are conducting the tests and assessments are binding.

Exclusion of consultancy services

Paragraph II.2.a) of the MEDDEV 2.10/2 demands that staff who are conducting the tests and assessments (including subcontractors) have to be independent and free of all obligations and influences which might compromise their objectivity. This includes any assistance with design, manufacture, distribution, etc. of the products in question, as well as conception, preparation, implementation or maintenance of QM systems to be audited. It follows that the exclusion of consultation demanded in paragraph II.2.c) relates equally to products and QM systems both for the purchaser themselves (including authorized agent and suppliers) as well as their competitors.