Life Sciences Products
Products must not be classified as medical device and do not require EC marking, but must be classified as RUO “Research Use Only products”.
Research Use Only
In compliance with the MEDDEV. 2.14/2 rev.1 February 2004, IVD GUIDANCE: Research Use Only Products
RUO products used for Basic Research:
These are products used for research conducted to study all aspects of human life in an attempt to better understand all underlying mechanisms. In such studies / experiments animal and / or human models are used. No medical purpose is defined, as the specimens taken are not being used for the purpose identified in the definition of an IVD device in the IVD Directive, article 1 2(b). In such practice there is no potential to misuse RUO products.
RUO products used in Pharmaceutical Research:
This is research conducted to find new drug compounds. The RUO products are used to verify the reactions to compounds in animal and / or human models. In such practice there is no potential to misuse RUO products.
Classification
Guidelines
In compliance with EC/98/79 of the Council of 27th October 1998 on in-vitro diagnostic medical devices.
Position of the French Health Products Agency since 1999 (AFSSAPS / ANSM) about State of STEM ALPHA products.
In compliance with the EC. MEDDEV. 2.14/1 rev. 1 January 2004, rev.1
IVD GUIDANCES: Borderline issues, A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES “Produits Frontière”
Recital 8 of Directive 98/79/EC states: Whereas instruments, apparatus, appliances, materials or other articles, including software, which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation.
In compliance with the MEDDEV. 2.14/2 rev.1 February 2004, IVD GUIDANCE: Research Use Only Products (RUO).