Study Group 1 Work Plan: 2005 - 2006

Principles of Medical Devices Classification

SG1/N015

Further progress awaits advancement of Conformity Assessment document.

1

2006/Q1

Principles of Conformity Assessment for Medical Devices

SG1/N040

Revised Working Draft completed should be available for public comment after September meeting.

1

2006 / Q2

Pilot testing of Summary Technical Documentation for Demonstrating Conformity to the Essential Principles for Safety and Performance (STED)

SG1/N011

Pilot started 2002 Q1 in some regions. US pilot extended for a further year.

1

2006 / Q2

Summary Technical Documentation for Demonstrating Conformity to the Essential Principles for Safety and Performance (STED)

SG1/N011

Proposed Document.

2

2005 / Q4

Information Document Concerning the Definition of the Term “Medical Device”

SG1/N029

Proposed to Steering Committee as Final document

2

2005 / Q3

Labelling for Medical Devices - Revision of SG1/N009

SG1/N043

Proposed to Steering Committee as Final document

3

2005 / Q3

Essential Principles for Safety and Performance of Medical Devices – Revision of SG1/N020

SG1/N041

Proposed to Steering Committee as Final document

3

2005 / Q3

Role of Standards in the Assessment of Medical Devices - Revision of SG1/N012

SG1/N044

Proposed Document -comments reviewed.

3

2005 / Q4

Classification of In Vitro Diagnostic Devices

SG1/N045

Working Draft discussed by SG1

4

2006 / Q2

Premarket Conformity Assessment for In Vitro Diagnostic Devices

SG1/N046

Sub-group preparing first draft

4

2006 / Q4