25 September 2019
On September 24th, TÜV SÜD awarded ISO 14155 certificates to three general hospitals of Korea University Medicine (KU Medicine) in Korea. With this certification, Korea University Medicine is able to claim compliance to the ISO 14155 standard when conducting clinical investigations with medical devices.
ISO 14155, Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice, provides detailed information regarding clinical investigation principles, the process of planning an conducting a clinical investigation, and the information to be collected. It specifies requirements to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, define responsibilities and assist parties involved in the conformity assessment of medical devices.
Medical device manufacturers located inside and outside of Korea can benefit from KU Medicine’s qualification. Partnering with KU Medicine as medical device study centre, with its three general hospitals, a wide range of medical disciplines and a certified and annually audited quality management system for medical device studies, provides all benefits of ISO 14155 compliance. This includes not only patient safety and high data quality, but also allows for greater efficiency in terms of study duration and costs.
“We are very pleased that all our hospitals of Korea University Medicine have been successfully certified. With this certification, we will be able to address the rapidly changing regulatory environment and contribute to the successful global market access of Korean medical devices,” said Prof. Kee-Hyoung Lee, Executive Vice President for Medical Affairs, Korea University Medicine.
“TÜV SÜD is among the world’s first certification bodies to receive designation as a Notified Body for the new MDR. We are happy to be able to contribute, together with Korea University Medicine, to patient safety, compliant and effective clinical studies and greater reliability and confidence in clinical evidence for medical device manufacturers, regulators, users and patients,” said Dr. Anthony Wilkinson, Head of the Global Clinical Focus Team at TÜV SÜD.
The ISO 14155 certificate award ceremony took place in Centennial Memorial Hall, Korea University on September 24th 2019, attended by representatives of TÜV SÜD and Korea University together with VIP guests including Prof. Jin-Taek Jung, President of Korea University, Mr. Wolfgang Hock, President & CEO of TÜV SÜD Korea, Dr. Anthony Wilkinson, Head of the Global Clinical Focus Team at TÜV SÜD, Mr. Stephen Auer, Ambassador of the German Embassy, and Mr. Hong-In Noh, Deputy Minister of Health and Welfare.
The European Union’s Medical Device Regulation (MDR) was officially published on May 5th, 2017 and came into force on May 25th, 2017. From May 26th, 2020, all medical devices including those who are already certified under the current directives will have to meet the applicable requirements of the MDR. Class lll and implantable medical devices manufacturers will be required to prepare Clinical Evaluation Reports (CER) based on clinical data from clinical investigations. These clinical evaluations have to be maintained and updated with post-market clinical data throughout the life cycle of a medical device.
According to the MDR these clinical investigations should be in line with international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, ensuring collection of data of good quality and quantity regarding the clinical question to be addressed.
From 2020, when MDR will come into force, manufacturers will have to present sufficient clinical data of justified quantity and good quality which can be shown based on compliance to ISO 14155. The prerequisite that those data collected out of the EU are accepted is also the fact, that the population treated with the device under conformity assessment is transferable to the EU population. In addition to the EU, many other markets accept ISO 14155 based clinical data and investigations for regional approvals, including U.S.A, Canada, Australia, Japan, China, and Russia. Therefore, the ISO 14155 certification of Korean University Medicine is going to be a milestone for the Korean medical device industry by vitalizing global market access of Korean medical devices.
Picture caption: Group photo of representatives of TÜV SÜD and Korea University together with VIP guests.
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Press-contact: Dirk Moser-Delarami