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4.1.2 Rationale
During applications of
in vitro
cell culture processing, the cells are subjected to
modification (genetic and/or substantial manipulation; Cell separation, concen-
tration or purification is not considered as substantial manipulation according
to Regulation (EC) No. 1394/2007) by pharmacological, immunological or
metabolic means as the principal intended action. The resulting cells are
therefore considered as Advanced Therapy Medicinal Product (ATMP) in Europe.
As a consequence, the components cannot be classified as Medical Devices.
Instead, the CliniMACS Formulation Unit is considered as manufacturing
equipment for cell-based medicinal products. Therefore, European GMP
guidelines (EudraLex Vol. 4) have to be followed when using the CliniMACS
Formulation Unit for manufacture of cell-based medicinal products in Europe.
For operating the CliniMACS Formulation Unit, only the stated products defined
in the respective applications must be used with and connected to the
CliniMACS Prodigy.
4.1.3 Compliance
The CliniMACS Formulation Unit conforms to the following directives:
2014/30/EU (Electromagnetic compatibility)
2011/65/EU Restriction of the use of certain hazardous substances in electrical &
electronic equipment (RoHS 2)
2006/42/EC (Machinery)
The instrument complies with the following standards:
• IEC 61010-1
• UL 61010-1
• CAN/CSA-C22.2 No. 61010-1
• IEC 60601-1-2
For applied standard version refer to the respective Product Quality Certificate.
The instrument complies to the following guideline: EudraLex Vol. 4.
