Requirements for combination products (medicinal product with a medical device component)

Extension of the transition period


In May 2017, the EU introduced more stringent requirements for medical devices and in-vitro diagnostics throughout Europe. Since Switzerland is integrated into the internal European market for medical devices, Swiss law is being adapted so as to maintain equivalence.

The amendments to the Therapeutic Products Act (TPA) and Human Research Act (HRA) ratified by the Swiss parliament on 22 March 2019 should originally have entered into force on 26 May 2020 along with the associated ordinances.

In connection with the COVID-19 pandemic, on 25 March 2020 the European Commission announced that it would defer the full applicability of the MDR by one year to 26 May 2021. This proposal was approved by the European Parliament on 17 April 2020 and by the European Council on 22 April 2020.

Switzerland’s continued aim is to achieve equivalence with EU legislation. The entry into force of the revised Swiss medical devices legislation will thus also be deferred by one year, to 26 May 2021. (Also see our publication dated 7 May 2020 on the website).

This also affects the new requirements announced in Swissmedic Journal 10/2019 for combination products, which will now also come into force on 26 May 2021.

The relevant documents, such as guidance documents and application forms, will be adapted to the new requirements and made available on the Swissmedic website in good time.