Since the entry into force of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) on May 26, 2021 and May 26, 2022, the Mutual Recognition Agreement (MRA) no longer applies between Switzerland and the European Union (EU) in relation to the 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 impact does this have?
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 authorized representative (CH-Rep).
CH-Rep: What does this mean in concrete terms for you as a medical device manufacturer?
Every manufacturer of medical devices who is not based in Switzerland or Liechtenstein requires a Swiss authorized representative (CH-Rep). This applies to all medical devices regardless of their risk classification. The duties of the authorized representative (CH-Rep) are governed by Article 51 MedDO. Accordingly, medical devices may only be placed on the Swiss market by the manufacturer “if he has authorized a person domiciled in Switzerland”. This authorized representative (CH-Rep) is responsible for the formal and safety-related issues in connection with placing the device on the market.
For the rights and obligations of the Swiss authorized representative (CH-Rep), the Swiss MedDO further refers to the (EU) authorized representative within the meaning of Art. 11 MDR, with which the role is readily comparable.
The same obligation to mandate a Swiss authorized representative (CH-Rep) also applies to importers of medical devices into Switzerland.
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 MedDO.
One advantage for you from the Swiss regulation of the MepV: The technical documentation can remain with you in accordance with Article 51 MepV. In the event of inquiries from Swissmedic as the competent authority, you transmit the documentation.
