Regulation (EU) 2017/745 according to Article 16 (4)

MDR-certification for distributors and importers carrying out activities referred to in Article 16(2)(a) and (b)


According to articles 53 and 54 of the Swiss Medical Devices Ordinance (812.213), distributors and importers carrying out certain activities, such as translating instructions for use or repackaging products, must provide a certificate from a Designated Body. SQS offers certifications to obtain these certificates, which are recognised in Switzerland.


After successful certification, you will receive the corresponding certificate and you will demonstrably have an effective quality system in relation to the activities described.

Target groups

Swiss distributors and importers of medical devices carrying out activities in accordance with MDR Article 16(2)(a) and (b).


3 years - after 12 to 24 months a surveillance audit takes place.


SQS is designated by Swissmedic with the identification number 1250. The SQS certificates are recognised in Switzerland.


Certification according to Article 16(4) is compliant with ISO 13485.

Lead Auditor
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