by Jan-Paul van Loon, Qserve Consultancy BV
On May 26, 2020, the new Medical Device Regulation (MDR) will come into force, and Hospitals and Industry are getting increasingly nervous as this date approaches. Although the MDR is not particularly stricter than the current Medical Device Directive (MDD) for custom-made device manufacturers, there are differences, as for example the necessity of a “Person Responsible for Regulatory Compliance”, and more extensive Post-Market Surveillance requirements.
The MDR puts more focus on “Clinical benefit” than the MDD, and therefore the defined “Intended Purpose” and the corresponding claims are increasingly important. This will be shown by discussing the intended use and the classification of different type of devices, as for example printed anatomical parts, surgical drilling guides, printing fluids, and the 3D printer itself.
What drives you?
Improving the life of people by helping medical device manufacturers getting their products CE certified.
Why should the delegate attend your presentation?
Understand the new / changed requirements for custom-made devices of the new Medical Device Regulation.
What emerging technologies/trends do you see as having the greatest potential in the short and long run?
The cost-price reduction of additive manufacturing.
What kind of impact do you expect them to have?
An increasing percentage of devices will be adapted to the specific patient.
What are the barriers that might stand in the way?
Regulatory requirements are increasing to such an extent that manufacturers will stop making medical devices or will not even start to do so.
Do not let the new Regulatory requirements stop you!
About Jan-Paul van Loon
Prior to working for Qserve Consultancy BV, Jan-Paul was co-founder and Chief Technology Officer for a medical device start-up, on a Class III heart assist devices. He is specialized in getting ideas to the market, including setting up the Quaity Management System and Technical Documentation.
Jan-Paul holds a Master degree in Biomedical Engineering and a PhD in Medical Sciences. He is the co-author of more than twenty scientific articles and co-inventor of three patented inventions, and the former secretary of the biomedical department of the Royal Dutch Society of Engineers.
About Qserve Consultancy BV
Qserve is a worldwide operating consultancy organization in the MedTech sector. We have supported hundreds of medical devices and In Vitro Diagnostics manufacturers with Global Market Access. We are highly specialized in Regulatory Affairs, Quality Assurance, Clinical Affairs, Clinical Trials, Training, and Auditing.