Extension of the new integrity requirement to medical devices under the revised Therapeutic Products Act
3 June 2019 – The new legal requirement of integrity pursuant to art. 55 of the revised Swiss Therapeutic Products Act (TPA), which was originally intended to apply only to prescription medicines, will now also cover medical devices. In its current spring session, the Parliament has extended the application of art. 55 revTPA – which comes into force in January 2020 – to medical devices and at the same time given the Federal Council the possibility to define exceptions. The Federal Council will specify these exceptions in the Ordinance on Integrity and Transparency in the Context of Therapeutic Products (OITTP; Verordnung über die Integrität und Transparenz im Heilmittelbereich, VITH). According to a recently amended press release (see here), it can be assumed that only “medical devices with an increased risk” will be covered by art. 55 revTPA and that the OITTP will contain exceptions for all other medical devices.