Since the Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) came into force on 26 May 2021 and 26 May 2022, the Mutual Recognition Agreement (MRA) no longer applies between Switzerland and the European Union (EU) in terms of medical devices regarding to MDR and IVDR. This means that the agreement to facilitate trade in CE-marked products between the EU and Switzerland will only apply to products that are still subject to the old legal situation in the form of the Medical Devices Directive (MDD) and the national laws based on it.
What are the implications?
With regard to MDR and IVDR, Switzerland is considered a third country. To counteract the effects of this, Switzerland has issued a new Medical Devices Ordinance (SR 812.213 – MepV) and a new In-Vitro Diagnostics Ordinance (SR 812.219 – IvDV).
Within these two laws there are many references to their EU counterparts. One innovation is the so-called Swiss authorised representative (CH-Rep).
CH-Rep: What does this mean in specific terms for you as a medical device manufacturer?
Every manufacturer of medical devices that is not based in Switzerland or Liechtenstein requires a Swiss authorised representative (CH-Rep). This applies to all medical devices regardless of their risk classification. The duties of the authorised representative (CH-Rep) are governed by Article 51 MepV. Accordingly, medical devices may only be placed on the Swiss market by the manufacturer “if he has authorised a person domiciled in Switzerland”. This authorised representative (CH-Rep) is responsible for the formal and safety-related issues in connection with placing the product on the market.
For the rights and obligations of the Swiss authorised representative (CH-Rep), the Swiss MepV further refers to the (EU) authorised representative within the meaning of Art. 11 MDR, with which the role is comparable.
The same obligation to mandate a Swiss Authorised Representative (CH-Rep) also applies to importers of medical devices into Switzerland.
How can BAYOOCARE Swiss help you as a CH-Rep?
BAYOOCARE Swiss helps you to place your products on the Swiss market in a compliant manner. We check your technical documentation and the need for any conformity assessment procedures in advance. We also take care of all communication with Swissmedic. This also includes taking over the vigilance reporting obligations under Article 66 of the MepV.
One benefit to you resulting from the Swiss regulation of the MepV: You can continue to keep the technical documentation in accordance with Article 51 MepV. In the event of enquiries from Swissmedic as the competent authority, you transmit the documentation.