EPMODEX AS YOUR NEW SWISS AUTHORIZED REPRESENTATIVE (SWISS AR)
As a Swiss Authorized Representative, we'll help you to continue your growth in selling your products in Switzerland.
On May 26, 2021, the European Medical Device Regulation (MDR) and along the temporary Medical Device Ordinance (MedDO) came into force.
All Non-Swiss Manufacturers therefore have to comply with specific Swiss requirements per MedDO. This includes the appointment of a Swiss AR for all medical devices imported into Switzerland.
With the termination of the negotiations of the Federal Council with the European Union (EU) on the Institutional Agreement (InstA) on May 26, 2021, the temporary Medical Device Ordinance (MedDO) has been automatically installed.
As a result, until a potential agreement on the proposed modification to the MRA is reached, the trade facilitating effects of the MRA for medical devices, including the mutual recognition of conformity assessment results, the absence of the need for an authorised representative and the alignment of technical regulations, no longer apply since May 26, 2021.
Therefore, all Non-Swiss Manufacturers will now have to comply with specific Swiss requirements per Medical Device Ordinance (MedDO) for medical devices. This essentially includes the appointment of a Swiss Authorized Representative (Swiss AR) for all medical devices imported into Switzerland. In addition to medical devices certified under MDR 2017/745 this includes products certified under the MDD, 93/42 EEC and AIMDD, 90/385 EEC.