Global Support for Manufacturers and Startups

With a wealth of experience in the industry, MedNet is dedicated to assisting manufacturers and startups not just in Europe, but also in Switzerland (CH) and the United Kingdom (UK). Our services are designed to meet the diverse regulatory requirements across these jurisdictions, ensuring that your products can be marketed efficiently and effectively.

Key Services Offered:

EC-REP Services for Medical Devices and IVDs: Ensuring compliance with EU regulations, MedNet provides comprehensive EC-REP services that support manufacturers in achieving market access.
CH-REP Services: For companies looking to enter the Swiss market, our CH-REP services facilitate compliance with local regulations, allowing for seamless product distribution across Switzerland.
UK Responsible Person (RP) : As the UK has established its own regulatory framework post-Brexit, MedNet offers Responsible Person services to ensure compliance with the UK's Medical Device Regulations.
Legal Representation for Clinical Trials: MedNet offers crucial legal representation for clinical trials, guiding manufacturers through the intricacies of regulatory approvals while maintaining compliance with relevant laws.
Free Sales Certificates: To facilitate international distribution, we help obtain Free Sales Certificates, a vital document attesting that your product is approved for sale in your home country.
GPSR Support: Under the General Product Safety Regulation (GPSR), we assist manufacturers with compliance for medical devices, IVDs, and general products, ensuring the safety and efficacy of your offerings.
Regulatory Support for Startups: We understand that startups often face unique challenges. Our team provides specialized regulatory support to help new companies successfully navigate the market entry process in the EU, Switzerland, and the UK.

News & Infos

Deadline Alert: Submission Requirements for MDR Conformity Assessment