M/095 - In vitro diagnostic (prog.)
In vitro diagnostic (prog.)
Mandate M/095 requests the European standardisation organisations to develop European standards for in vitro diagnostic medical devices. The mandate aims to support the regulatory framework by ensuring the safety, performance, and reliability of these devices through harmonised technical specifications. This facilitates market access and enhances public health protection across the EU. The standards will cover various aspects relevant to in vitro diagnostics, including design, manufacturing, and testing procedures, to ensure consistent quality and compliance with relevant legislation.
Purpose
This mandate concerns the development of European standards for in vitro diagnostic (IVD) medical devices. The objective is to support the implementation of EU legislation and enhance the safety, performance, and reliability of IVDs across the internal market.
Standardisation request
The European Commission requests the European standardisation organisations (ESOs) to prepare harmonised standards and other deliverables relating to in vitro diagnostic devices. These standards should cover design, manufacturing, and performance evaluation to ensure compliance with relevant EU regulations.
Expected deliverables
- Harmonised standards for various types of in vitro diagnostic devices, addressing general safety and performance requirements.
- Technical specifications and guidelines facilitating conformity assessment procedures.
- Normative documents to support market surveillance and post-market monitoring activities.
Context
In vitro diagnostic devices play a critical role in healthcare by enabling the examination of specimens derived from the human body for medical purposes. Standardisation in this sector is vital for ensuring high-quality diagnostic results and patient safety. This mandate aims to align European standards with the regulatory framework governing IVD devices, thereby fostering innovation and harmonisation within the EU market.
The mandate covers standardisation work related to in vitro diagnostic medical devices, including their design, manufacture, and performance. It focuses on ensuring safety, reliability, and effectiveness in diagnostic tests used for medical purposes, supporting regulatory compliance and harmonisation across the EU market in this sector.
General Information
ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
- Standard26 pagesEnglish languagee-Library read for1 day
ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
- Standard26 pagesEnglish languagee-Library read for1 day
ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
- Standard22 pagesEnglish languagee-Library read for1 day
ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
- Standard22 pagesEnglish languagee-Library read for1 day
This part of IS0 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
- Standard18 pagesEnglish languagee-Library read for1 day
This part of IS0 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
- Standard18 pagesEnglish languagee-Library read for1 day
This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
- Standard12 pagesEnglish languagee-Library read for1 day
This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
- Standard12 pagesEnglish languagee-Library read for1 day
Frequently Asked Questions
A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.
M/095 is a European Standardization Mandate titled "In vitro diagnostic (prog.)". In vitro diagnostic (prog.) There are 8 standards developed under this mandate.
Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.