Hi All,

I have to agree with most of you regarding 3D printed medical devices becoming a popular trend. I currently work in a pharmaceutical company handling design controls and Risk management activities for their combination products. I see that many companies now are working hard to reveal the many possibilities that 3D printing brings to the table. The main issue with 3D printed medical devices is that it does not have established precedents yet. There are no clear testing standards and long term use effects are not yet clear. The regulatory agencies have very limited experiences dealing with 3D printed medical devices. This will result in a harder approval pathway for manufacturers.

On the other hand, I agree with Dr. Simon that most medical device manufacturers are going for EU approval first since it is the easier pathway to European Union markets and some middle east countries. The recent draft of the Medical Device Regulations (MDR) issued by the Council of European Union in June 2016 raises the bar of the EU regulatory requirements very close to the FDA requirements.

Finally, The recent “21st Century Cures Act” signed into law have redefined the classification of applications and software into medical devices. Some software have been granted exclusions from the medical device classification.