1992 -

Working Towards Harmonization in Medical Device Regulation

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Study Group 1 (SG1) - Premarket Evaluation

Purpose of Study Group

SG1 has been charged with comparing operational medical device regulatory systems around the world and from that comparison, isolating the elements / principles that are suitable for harmonization and those that may present obstacles to uniform regulations. In addition, the group is also responsible for developing a standardized format for pre-market submissions and harmonized product labelling requirements.

Study Group Details

• Study Group Chair
• Participants
• SG1 Work Plan
• IVD Subgroup Participants

Documents

• Proposed Documents - (for review & comments)
• Comments Template - (for use in providing comments on proposed documents)
• Final Documents
• Archived Documents

• Meeting Summaries

Updated 21 November 2007

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