medicaldeviceslegal

On 16 July I had the honor to give a lecture about Legal and Regulatory Aspects of 3D Printing (and biofabricaton) in the Focus on Life Sciences Summerschool program of University Medical Centre Utrecht, the Netherlands university hospital that made the headlines with a complete cranial replacement that was 3D printed.

Partly old, partly new

The lecture contains much of my thinking that is contained in my previous post on this blog about quality system aspects of 3d printing of medical devices under the draft Medical Devices Regulation and a discussion of the question whether 3d printed medical devices should fall within the custom made devices regime in the first place. This is a discussion that seems to have been picked up in the legislative process (I saw signals to this effect in the Council Working Group documents), but we’ll have to see where it lands.

IP, ATMP and PD

In this lecture I have also addressed aspects of 3d printed / biofabricated ATMPs, device – ATMP integration, intellectual property issues and personal data issues, each of them very thorny regulatory issues as the audience agreed with me. Not only thorny, but also questions that the law often has no answer for (yet).

Fact free

The audience – mostly incredibly intelligent engineers and physicians – was amazed that there was so little medical expertise part of the regulatory approval and legislative processes. They lost a few illusions about law making in life sciences when I discussed the slow response times and sometimes totally fact free nature of the legislative process.

Outlook

Many of the regulatory and legal issues that the law currently deals with are fixes made on the fly, that’s the nature of regulation of life sciences it seems. Risk averse regulators do not always make the right choices and can even upset a complete industry, as happened with the ATMP Regulation in Europe. This regulation was supposed to be friendly to innovative small and medium sized companies, but instead caused them to massively flee into exemptions and business models that do not even include seeing a product through to market access rather than take their chances with the regulatory process. Do we want this for yet another industry that has enormous potential to meet medical needs? I don’t think so. We do not need fact free fear based regulation written by people that do not understand the technology, nor do we need technology that addresses 3d printing with the same regulatory burden as producing customized wooden peg legs.What do we need? I like to think that I made some sensible proposals for 3D printing here.