Authorised Representatives

Medical devices are regulated by the Swiss Agency for Therapeutic Product Manufacturer Responsibility 1.Ensuring medical devices are placed on the market is in accordance with the requirement of the medical device ordinance. 2.Affixing the conformity mark and carrying out clinical evaluation according to Article 61 EU MDR. 3.Keep technical documentation, declaration of conformity & any other certificates updated. 4.At the request of a competent authority, the manufacturer should submit...

Switzerland Market Situation Switzerland Market Situation – Downside Switzerland- Medical Device Regulations Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturers Outside Swiss – Proxy to the foreign manufacturer – Responsible for product safety – Liable for product defects – contact person for Swiss authorities – can be a legal entity or a natural person – must have access to PRRC Roles of Swiss AR’s PRRC Liability of a Swiss AR Manufacturer Re...

MEDICAL DEVICE REGULATION UPDATE IN SWITZERLAND 1. Who is responsible for medical device regulation in Switzerland? The Swiss Agency regulates medical devices for Therapeutic Products (Swiss medic) 2. Which current Switzerland medical device regulations need to be followed by stakeholders? From May 26th, 2021, Stakeholders need to follow the revised Medical Devices Ordinance. (MedDO) and a new Ordinance on Clinical Trials with Medical Devices (CTO-Medd). 3. What is the EU- Switzerland mutual rec...

Obligations of the Switzerland AR Responsibilities 1. Verify the DoC and technical documentation have been drawn up and where necessary conformity assessment procedure has been carried out. 2. Keep available a copy of the technical documentation, the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at the disposal of competent authorities for a period as defined in the section «Records» of this agreement. 3. Register it...

1. Manufacturers outside Switzerland will need to appoint Swiss AR. 2. The Manufacturer will use commercially reasonable efforts to update its technicaldocumentation for the devices, to comply with the requirements of the ordinance, and to complete a conformity assessment procedure for devices in due time prior to the expiration of their current certificate of conformity. 3. The Manufacturer reserves the right but needs to inform AR about any discontinuities of the devices upon expiration of the...

Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying document.” The provision for indication of CH-REP comes into effect on 26 May 2021 and is timeline based, applicable to devices of all classes (Class I, IIa, IIb, III)....

Medical device nomenclatures are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating human beings. To learn more about medical devices, read our article on the definition of a medical device. This article discusses the nomenclature of medical devices and examples of these. What is the Nomenclature of Medical Devices? To simply put it, the nomenclature is the naming of a me...

Switzerland is a premier destination for medical device manufacturers relying on sophisticated micromanufacturing or advanced precision techniques. This appeal is evident in Switzerland’s choice of EMEA headquarters for industry leaders. The country boasts one of the world’s highest proportions of GDP derived from the manufacturing sector, driven by traditional watchmaking, MEMS, and Medtech industries. These sectors have cultivated highly industrialized, digitized precision cluste...