Strategies for effective corporate participation in standards development and implementation

Area of Science:

• Regulatory Affairs
• Quality Management Systems
• European Union Directives

Background:

• European Community (EC) 1992 presents regulatory challenges for businesses, particularly medical device manufacturers.
• Compliance with EC directives, such as obtaining the CE mark, is crucial for market access.
• Companies need strategic approaches to ensure preparedness and avoid delays.

Purpose of the Study:

• To outline strategies for EC 1992 preparedness within organizations.
• To highlight the importance of internal champions and coordinated efforts.
• To guide companies in navigating the CE mark process and regulatory landscape.

Main Methods:

• Establishing a dedicated internal champion for EC 1992 compliance.
• Implementing centralized coordination for large corporations with similar divisions.
• Utilizing external resources like standards-setting organizations (e.g., AAMI) and consultants.
• Leveraging existing experience and staff resources in the US and Europe.
• Accessing training for internal auditors and quality assurance personnel.

Main Results:

• Proactive preparedness minimizes delays and difficulties in obtaining the CE mark.
• Cooperation in standards-setting ensures a level playing field for suppliers.
• Internal auditors can be trained to support compliance efforts.
• Information on EC 1992 is readily available through publications and consultants.

Conclusions:

• Appointing an EC 1992 preparedness champion is essential for every company.
• Centralized coordination benefits large corporations with similar operations.
• Active engagement with standards bodies and consultants facilitates compliance.
• Adequate resources and training are available to support companies of all sizes in achieving EC 1992 readiness.