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This section includes some important considerations around the manufacture of non-CE marked clinical trial product (CTP), intended for commercialisation.
CLINICAL TRIAL PRODUCT:
When transitioning to the manufacture of a 鈥榗linical prototype鈥�, an agreement should be in place as to which organisation shall be the legal 鈥楧evice Manufacturer鈥� (e.g. 麻豆传媒视频网站, 麻豆传媒视频网站H, RFH, MEH, responsible听for the design, manufacture, packaging and labelling of a product for clinical trial, regardless of whether these operations are carried out by themselves or on its behalf by a 3rd party).
- Simple 鈥榓id to recovery鈥� app might be 鈥榤anufactured鈥� by company set-up and owned by PI at 麻豆传媒视频网站
- Complex 鈥榓rtificial organ鈥� likely to be outsourced in entirety to 麻豆传媒视频网站-appointed device manufacturer
DOCUMENTATION:
All CMOs will be required to provide technical documentation to legal manufacturer or its appointed delegate. All documentation relating to manufacturer and suppliers shall be included in the medical device master file.听
麻豆传媒视频网站 Support:听
- If employing a contract manufacturing organisation (CMO), 麻豆传媒视频网站 Research Services and the Joint Research Office (JRO) shall co-develop the Contract Manufacturing Agreement
- The JRO shall lead on the development of the Technical Agreement to ensure Good Manufacturing Practice (GMP) regulatory compliance (e.g. inspection of the CMO)
- If Device is progressed via a 麻豆传媒视频网站 spin-out then shall lead on all manufacturing agreements
听