Swiss Authorised Representative according to Art. 51, Para.1 MepV (CH-REP)
Continue to obtain market access for your medical devices in CH
Switzerland has revised its Medical Devices Ordinance (MedV) to align it with the EU MDR (Reg. (EU) No. 2017/745) and to bring it into force on May 26, 2021. According to the revised version of the MedV, non-Swiss manufacturers require a Swiss Authorized Representative (Swiss Rep) based in Switzerland to be able to sell their CE-marked medical devices in Switzerland. Due to the failure to update the Mutual Recognition Agreement (MRA) between Switzerland and the EU, which includes the EU MDR, medical device manufacturers based outside Switzerland must authorize a Swiss Rep in accordance with the revised MedV.
The definition of a Swiss Rep under the MepV is as follows: "any natural or legal person established in Switzerland who is mandated in writing by a manufacturer established abroad to perform on his behalf certain tasks in fulfilment of obligations of the manufacturer arising from this Ordinance".
Once the mandate has been accepted, the Swiss authorised representative acts as the representative of the foreign manufacturer vis-à-vis the competent Swiss authority Swissmedic and is jointly liable with the manufacturer for defective products.
semperhogg gmbh offers you comprehensive CH REP services including advice and support for the measures you need to implement (e.g. labeling, adjustments to documents) with an offer tailored to your needs depending on the risk class of your medical device and the necessary activities.
Our CH REP service includes (according to the current, revised MepV):
- Ensuring compliance with Swiss registration requirements
- Verification of the device labelling according to CH requirements
- Provision of a copy of or access to the technical documentation and the corresponding declarations of conformity for the CH authorities
- Cooperation with Swissmedic in CAPA, audits and possible provision of product samples
- Ensuring and fulfilling vigilance obligations in case of incidents or safety corrective actions (FSCA)
Range of services / competences
- semperhogg gmbh has several years of experience in various projects and other activities for leading global medical technology companies in the areas of Regulatory & Quality Management according to ISO 13485 as well as certification according to MDR.
- semperhogg gmbh customers benefit from a secure digital platform for smooth data exchange as well as rapid response times when needed.
- semperhogg gmbh also supports you as a coach in compliance issues or in questions of market access in Switzerland and acts as a close contact to the Swiss authorities.