On January 18, 2018 IMDRF published GRRP WG(PD1)/N47 Essential Principles of Safety and Performance of 19 Medical Devices and IVD Medical Devices.
The IMDRF Good Regulatory Review Practices group published the draft guidance as part of an IMDRF consultation.
The document’s intention is to help harmonize documentation and procedures to assess whether a medical device conforms to the regulations that apply in each jurisdiction.
The document’s content is:
- Introduction
- 1.0 Scope
- 2.0 References
- 3.0 Definitions
- 4.0 Safety and Performance of Medical Devices – General Principles
- 5.0 Essential Principles Applicable to all Medical Devices and IVD Medical Devices
- 6.0 Essential Principles Applicable to Medical Devices other than IVD Medical Devices
- 7.0 Essential Principles Applicable to IVD Medical Devices
- Annex A: Use of Standards in Meeting Essential Principles
- Annex B: Guidance on Essential Principles
Download the document at http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-epsp-n47.pdf