Unitron Regulatory workshop on Medical Device modifications
This particular aspect of the medical device life cycle is often overlooked, as receiving a CE mark for a medical device is very often perceived as the crown jewel and the end of the road. Yet the new MDR regulation makes it very clear that obtaining a CE mark is but a milestone in the whole life cycle of a medical device, and highlightens the obligations of the manufacturers for proactive surveillance of the devices working in the field, to gather information for updating its technical documentation, such as the Risk Management File, Clinical Evaluation Report or instructions for use. Furthermore, if the obtained PMS information requires the manufacturer to modify the device to either address a safety issue or improve its overall performance, the device modifications should be properly documented and implemented in the manufacturing process; it should be kept in mind that certain types of modifications would require involvement of the Notified Body that issued the CE mark for this particular device.
For properly addressing the device modification from regulatory and practical point of views, the workshop was divided into two parts. The first part gave high level overview of the applicable regulations and the technical documentation needed for a medical device in order to comply with these regulations. In the second part the design change management itself was discussed. The procedures coming from a Quality Management System prescribed by ISO 13485:2016 were listed and examples given what type of documents from the technical documentation should be modified following those procedures, including useful tips from a practical viewpoint. To practice with design change management, the participants were divided into small groups. The groups were instructed to take any medical device and subject it to an impact analysis for a possible modification to that device, on device documentation and QMS procedures.
Techmed Living Lab is a European initiative to support innovation in the healthcare sector and to shorten time required for going from a concept to a product that can be put on the market. It is aimed to help people who already have a working concept of a new device and wish to increase its Technological Readiness Level (TRL) to make a medical device suitable for the real world. To achieve program goals, the partnership between Twente University, Holland Innovative, Panton and Unitron was formed where each partner brings his expertise to help researchers and entrepreneurs to better understand challenges and underwater stones on the way to creation of a medical device. One of the outcomes of the program was a series of TechMed Workshops, each covering a different aspect of the medical device life cycle starting from user friendly device design till reliable manufacturing of the devices and implementation of modifications based on information received from device performance in the real world. During those free workshops various audience coming from academia, hospital and manufacturing worlds could sit together to watch the presentation by a speaker from one of the partners and then participated in group activities proposed based on one of the topics presented earlier in the session.