I am very much looking forward to the Medical Device Clinical Trial Regulations and Practice Seminar in Taipei September 5th, where I will be speaking on the current EU standards regarding Clinical Evaluations and Clinical Trials as well as the mutual acceptance of foreign clinical data.
The European Regulatory environment regarding clinical evaluations and clinical investigations shows a clear trend towards higher standards of evidence for medical devices with Revision 4 of the MEDDEV 2.7/1 and the upcoming MDR. ISO 14155 or any equivalent GCP is becoming the standard for any clinical study, Pre- as well as Post-market, when planning on using the collected data for support of device safety or performance. More-over, the clinical evaluation has become an ongoing process throughout the full product life cycle, will require manufacturer owned data, and will be needed for all medical device classes. This is very much in line with the developments in the mutual acceptance of foreign clinical data as I previously blogged about, and we see recent publications of guidelines in that respect from the FDA as well as the CFDA.
Do not hesitate reaching out to me in case of any questions or support needed in the collection of clinical evidence for your medical device.