18 April 2018
Therapeutic Products Act and the Human Research Act: call for public input
Subsequent to several incidents and scandals relating to medical devices, the EU has revised its current medical device legislation. The EU Commission has proposed two new, more stringent Ordinances to replace the previous Directives: one for medical devices and the other for in vitro diagnostics. The proposed revisions should ultimately improve quality and safety of medical devices and harmonise their implementation in the EU, thereby enhancing their safety for patients.
Due to a Mutual Recognition Assessment between Switzerland and the EU market, Switzerland must follow suite, proposing adaptations to its legal framework so that Swiss-based patients can also benefit from better patient safety and greater transparency regarding medical devices. Accordingly, the Therapeutic Products Act (TPA) and the Human Research Act (HRA) must also both be adjusted. The Federal Council is calling for public input on these two acts. The deadline for submissions is 11 June 2018.
Relevant documentation is available from the Federal Office of Public Health website in French, German, and Italian, plus an overview in English. Please consult our tables in French and German, summarising proposed changes to the TPA and HRA.