CEN/TC 258/WG 2 - Clinical investigation plans
To provide a framework for the organisation and content of clinical investigation plans which would include requirements specifically intended to ensure rigour and scientific value. To draft relevant documents dealing with the review of the scientific literature to, inter alia, support clinical investigation plans and assist the analysis of clinical data.
Clinical investigation plans
To provide a framework for the organisation and content of clinical investigation plans which would include requirements specifically intended to ensure rigour and scientific value. To draft relevant documents dealing with the review of the scientific literature to, inter alia, support clinical investigation plans and assist the analysis of clinical data.
General Information
Frequently Asked Questions
CEN/TC 258/WG 2 is a Working Group within the European Committee for Standardization (CEN). It is named "Clinical investigation plans" and is responsible for: To provide a framework for the organisation and content of clinical investigation plans which would include requirements specifically intended to ensure rigour and scientific value. To draft relevant documents dealing with the review of the scientific literature to, inter alia, support clinical investigation plans and assist the analysis of clinical data. This committee has published 2 standards.
CEN/TC 258/WG 2 develops CEN standards. The scope of work includes: To provide a framework for the organisation and content of clinical investigation plans which would include requirements specifically intended to ensure rigour and scientific value. To draft relevant documents dealing with the review of the scientific literature to, inter alia, support clinical investigation plans and assist the analysis of clinical data. Currently, there are 2 published standards from this working group.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Working Group in CEN is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.
1 Scope
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.
- Standard20 pagesEnglish languagee-Library read for1 day
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.
- Standard14 pagesEnglish languagee-Library read for1 day