Revised requirements regarding combination products


Swissmedic defined the requirements for integral and non-integral combination products (medicinal products with a medical device component) on page 510 of Swissmedic Journal 06/2017. According to this Swissmedic Journal publication, applications for an integral combination product that lacks certification from a conformity assessment body must demonstrate that the medical device component satisfies the applicable basic requirements of Annex I of the European Medical Devices Directive 93/42/EEC (usually performance and safety).

On 26 May 2017, the new Regulation of the European Parliament and of the Council on medical devices (MDR) was adopted. It takes effect in the EU as of 26 May 2020. The Medical Device Directive 93/42/EEC currently applicable in the EU will then cease to apply.  Swissmedic intends to adapt its authorisation requirements for integral combination products to the revised provisions of the European MDR:

As of 26 May 2020, applications for the authorisation of integral combination products must demonstrate that, unless it bears a CE certification mark, the medical device component satisfies the applicable basic safety and performance requirements of Annex I of the new MDR. Furthermore, in keeping with Article 117 MDR, a “Notified Body Opinion” must be submitted for integral medical device products of classes Is, Im, Ir, IIa, IIb and III that do not have a certification from one of the designated conformity assessment bodies. For the practical implementation of Art. 117 MDR, Swissmedic will align itself to the EU's specification documents, in particular the “Guideline on the quality requirements for drug-device combinations” (EMA/CHMP/QWP/BWP/259165/2019), which is currently available in draft form, as well as the EMA's Questions & Answers document (EMA/37991/2019).

Swissmedic will adapt its application forms to the new requirements in good time and make them available on its website. A correspondingly revised version of the guidance document Formal requirements HMV4 will be published by the time the new MDR enters into force at the end of May 2020.