MEDIMARK EUROPE

On 10 August 2021, Swissmedic published a information sheet on the obligations of Swiss economic operators. This was done with the aim of answering as many of the industry’s open questions on the implementation of the Medical Devices Ordinance (MDO) as possible in a timely manner. This leaflet provides economic operators (authorized representatives, importers and distributors) with an overview of the requirements of the revised MDO that are relevant to them. In addition to the obligations, terminology is explained, transitional provisions are set out and it is shown which information must be indicated on a product. Regarding the designation of a CH-REP (Swiss authorized representative), the delays are as follows:
  Class III or IIb Implantable: 31 December 2021
  Class IIb Non-implantable and Class IIA: 31 March 2022
  Class I: 31 July 2022