History/Milestones

Founded in 1994 we belonged to the first Notified Bodies, which were recognized under the European Medical Device Directive 93/42/EEC and could start to offer services in the area of CE marking of medical devices. From the beginning we have performed audits and certifications of quality systems according to international standards for quality systems.

Since that time we have expanded our range of services without leaving the original sector of medical devices, healthcare and related areas. Besides the continuous extension of our services the merger with the Notified Body „Zertifizierungsstelle Medizinprodukte von ZDH-ZERT e. V.” was a milestone in our history. This was an important basis for the growth of our company which we have reached during the last years. Important steps were also the foundation of our subsidiaries in Berlin in 2010 and Vienna in 2016.

Declaration of independence and interest by the top management:

The management of mdc declares the following on behalf of the entire top management:

Not only legal and normative requirements, but the general character of our activity as a Notified Body and accredited certification body dictates that we commit ourselves to maintaining independence, objectivity, neutrality and confidentiality at all levels.
Our employees, as well as our external staff, have committed themselves in writing to independence, objectivity, neutrality and confidentiality. For this reason, they are generally prohibited from performing advisory activities or clear limits are imposed on them within the framework of the normative requirements.
We are not the designer, manufacturer, supplier, assembler, commercial purchaser, owner, maintainer or other economic operator of the products we assess.
Our remuneration and the remuneration of our employees are neither dependent on the number nor on the results of the assessments or other conformity assessment activities carried out.
We are free from any interests of commercial, financial or other nature, which might lead us to act in a biased or discriminatory manner. In particular, we neither own any shares, stocks, bonds or investment certificates, nor any assets or liabilities in any entity to be audited or certified (except for shares or other ownership interests in collectively managed funds over whose selection we have no control).
We neither accept nor grant advantages.
All decisions on the granting of certificates are made by internal staff who were not involved in the assessment. Should a decision made by mdc regarding the granting, refusal, restriction or suspension of a certification repeatedly not be accepted, a neutral arbitration procedure may be invoked.

Compliance with impartiality is regularly reviewed and assessed by an independent supervisory body.

CE Marking Services