Audit of Companies for Manufacturing and Trade of Medical Devices

GG 32Β/16.01.2004

Certification of companies trading and maintaining medical devices became mandatory in Greece with the Ministerial Decision Ε3/833/99, December 2000.

Since January 2004 the new Ministerial Decision DΥ8/1348/2004 has been applied and has replaced the previous one.

TÜV HELLAS, through the accreditation of TÜV NORD CERT GmbH (nr. 0044) for both European Directives - 93/42/EEC for medical devices and 90/385/EEC for the active implantable medical devices – has the competency of performing audits according to DY8/1348/2004, and Certificates (Attestations) are issued by Notified Body TUV NORD CERT GmbH 0044. As clarified by Competent Authority, National Pharmaceutical Organization (EOF), this Min. Dec. is mandatory for all companies involved in the distribution channel of Medical Devices (importers, distributors, service/maintenance providers, logistics, transport agents etc.)

The Competent Authority National Pharmaceutical Organization (EOF), is also informed about the certificates /attestations according to the requirements of the Ministerial Decision The great experience of more than 20 years of the TÜV HELLAS auditors in the sectors of design, manufacturing, sterilization, standards management, application, usage and audits of medical devices, as well as the recognition and credibility of the TÜV NORD CERT GmbH certificates, offer added value to the companies that trade and service medical devices.

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