28/29 January 2020
With the entry into force of the Advanced Therapy Medicinal Products (ATMPs) GMP rules as Part IV of the EU GMP Guidelines, a new chapter has been opened on the manufacture and quality control of ATMPs. Special requirements are placed on the QP when an ATMP is combined with a medical device.
These GMP rules are very individually adapted to ATMPs. This also applies to ATMPs that are combined with a medical device (combination product, drug-device combination, DDC). In addition, with the entry into force of the EU Medical Devices Regulation (MDR) on May 25th 2020, requirements for the proportion of medical devices will also change. The QP should be aware of this medical device proportion. When releasing such combination products, the QP should ensure that the medical device part meets the general safety and performance requirements of EU law and is suitable for combination with the ATMP. This requirement is important because if the medical device fails, the entire product will fail.
The QP should also pay special attention to the specifications of the medical device in the case of ATMP clinical samples containing a medical device.
Conclusion: Qualified persons (QPs) who want to release an ATMP that is combined with a medical device must also be aware of the regulatory requirements for medical devices when the ATMP is released.