Establishing Compliance with the Medical Device Directive 93/42/EEC (MDD)

Training Course Summary

This three day training course covers the content of the Directive in some detail and the intention is to assist delegates in becoming familiar with its provisions. All key aspects are addressed, enabling participants to navigate between the Articles and Annexes with confidence. It is designed to be of assistance to personnel within quality assurance and regulatory affairs departments, and to staff within Notified Bodies and Competent Authorities who are expected to audit against the Directive or to administer its provisions.

Objectives

In the context of compliance with the MDD (93/42/EEC) to understand:

• The role of European Directives
• Legal necessity for compliance
• The structure of the Directive
• The mechanisms of compliance
• The importance of the concept of risk
• How to find the key elements within the text of the Directive
• The roles of the various functions within the organization including those at all levels of management
• The role of external bodies such as Notified Bodies and Competent Authorities

For whom intended

Anyone within the company’s management structure whose role is impacted by the requirement for the organization to comply with the MDD or EN ISO 13485:2003 but in particular:

• Quality assurance personnel
• Regulatory affairs personnel
• Notified Body auditors
• Competent Authority personnel involved in the enforcement of the Directive

Pre-requisites

Delegates will be expected to have educational levels appropriate to the functions listed above. Some familiarity with the MDD and EN ISO 13485:2003 would be an advantage but is not a requirement.

Registration

• On line
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• Off line
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