PRRC Compliance Services
U-Represent, Authorised Representatives in Switzerland & EU for PRRC Services, MedDO & MDR, EC-REP CH-REP. Expert Legal Representation & Documentation for Medical Devices & EUDAMED Submissions. Contact Us for PRRC Compliance Services.
We take the unstable situation seriously, our team of experts with cumulative 25+ years in the medical market will ensure you will not be putting aside or lose market share to competition.
We execute work under strict confidentiality policies and store files in secured and protected area.
We act and provide services as Authorised Representative (AR) for all medical devices. We establish strong regulatory support and documents conformity for Swiss market and EU market.
document review
We quickly pre-inspect your documentation to make sure full compliance protocol as per the market regulations and the revised Medical Device Ordinance (MedDO) or revised EU MDR (Reg. (EU) No. 2017/745). All under pre-signed confidentiality agreement.
of documents
We make sure the documentation is in the suitable format requested by the local regulations. If not, we translate, re-format and advise along with accurate communication with client.
and storage location
We store safely and in total privacy the copy of technical documentations, CoC, and all files requested under MedDO or EU MDR. Also, we make them available to the national authorities on demand during 10 to 15 years depending on the class of the device.
in EUDAMED
We provide system submit services in full compliance with products registrations under MedDO and EU MDR.
Surveillance monitoring
We keep track on Post Market Surveillance (PMS) and communicate to the appropriate parties as fast as possible on any findings, claims or actions to take.
U-Represent is the legal division of U-Impl Switzerland GmbH based in Biel Switzerland since 2008. U-Impl Switzerland GmbH is a manufacturer of dental products and medical metals trader. Also, our EU legal office is in Žilina, Slovakia since 2015. In this period of uncertainty, we decided to help the medical industries in Europe by giving them the option to keep at lower price the access to Switzerland and EU markets after May 26th, 2021. We believe this situation is temporary and we know that the best cost-effective decision is to assign an experienced representative, instead of investing in the creation of a Swiss/EU based company or any other creative ideas which could put you at risk.
Contact an experienced regulatory professional to start the registration
