British Standards Institution

Source:: CEN/CLC
Committee:: CH/210 - Quality management and corresponding general aspects for medical devices
Categories:: | Medical equipment. General

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

09/10/2017

3. Public Comments (Complete)

4. Comment Resolution (Complete)

Comment Resolution start date:

16/11/2017

5. Approval (Complete)

6. Publication

Publication start date:

21/03/2018

Learn more about the standards development process

Standards Development

PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

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