EC REP Medical Devices European Authorised Representative
In responsabletecnico.eu we offer services as a qualified European Authorised Representative (EC REP). We always provide a high standart of services, including a personal implication to solve any querie from european authorities or any compliance issue. Our fees are competitive and affordable for a wide range of non-EU manufacturers.
We can also prepare the product Technical File and provide services as a EU Regulatory Consultant in order to assure compliance of EU regulations.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices states:
«For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union.» «Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer’s person responsible for regulatory compliance.»
If you are interested in receiving Medical Devices European Authorised Representative Services, you need a product Technical File development and/or you need regulatory consultant services, you can write us to francesc@soma.cat or using the following contact form:
CONTACT FORM
Deja una respuesta