On 5 April 2017, the European Parliament approved the Regulations (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and 2017/745 on medical devices (MDR). These new Regulations entered into force on 26 May 2017 and shall apply with graduated transitional periods ranging from 6 months to 5 years, from the spring of 2021 (MDR) or the spring of 2022 (IVDR) respectively. Switzerland is guided by European law in the case of medical devices.
In its publications from 2017 (SMJ 06/2017), 2019 (SMJ 10/2019) and 2020 (SMJ 05/2020), Swissmedic has already provided information on integral and non-integral combination products and specified when the new requirements will take effect. Following the one-year extension of the transition period, the new requirements will now come into force on 26 May 2021.
As of this date, applications for the authorisation of integral combination products must demonstrate that, unless it bears a valid CE certification mark, the medical device component satisfies the applicable basic safety and performance requirements of Annex I of the MDR. Furthermore, in keeping with Article 117 MDR, a “Notified Body Opinion” must be submitted for integral medical device products of classes Is, Im, Irsi, IIa, IIb and III that do not have a certification from one of the designated conformity assessment bodies (i.e. that do not have a CE certificate). These must be integrated into module 3.2.R.
As previously, the suitability of the medical device component for the specific medicinal product in the proposed combination must be demonstrated. The requirements in this regard can be found in the EMA guideline on combination products (see the EU specification documents below).
For the practical implementation of Art. 117 MDR, Swissmedic will align itself to the EU's specification documents, in particular:
- Guideline on the quality requirements for drug-device combinations (EMA/CHMP/QWP/BWP/259165/2019) (currently in draft form) and
- Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) (EMA/37991/2019)
The relevant Swissmedic specification documents such as the guidance document Formal requirements HMV4 and the form New authorisation of human medicinal products HMV4 will be adapted accordingly.