ATZ Healthcare

About ATZ Healthcare

We bring your medical device into Switzerland and the EU and provide the legal infrastructure. Market access Switzerland Swiss authorized representative according to the Medical Devices Ordinance Any manufacturer who is not based in Switzerland and would like to place their medical devices on the Swiss market must appoint an authorized representative within Switzerland. The tasks of a Swiss representative essentially correspond to those of an EU representative. After being commissioned, you have a Swiss authorized representative and a representative vis-à-vis the responsible Swiss supervisory authority, Swissmedic. This covers liability for defective products. Market access EU External responsible person for regulatory provisions according to Art. 15 MDR (PRRC) In the EU, a "person responsible for regulatory provisions according to Art. 15 MDR" is required for placing medical devices on the market. According to EU Directive 2003/361/EC, companies with fewer than 50 employees and an annual balance sheet of no more than EUR 10 million may use an external PRRC. They are exempt from the obligation to hire a PRRC themselves. EU representative according to MDR In the European Union, any foreign manufacturer wishing to sell their equipment there is required to be represented by an authorized representative (EC REP) with a physical office in one of the member states. ATZ Healthcare will represent your company vis-à-vis the authorities and register your medical device in the appropriate IT system before it is marketed. ATZ Healthcare installs the Authorized Representative structure according to MDD/MDR and IVDD/IVDR. With the introduction of the MDR and IVDR, the authorized representative is considered an economic operator and is jointly and severally liable with the manufacturer for claims for damages.

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