MedPass International is the leading Europe Medical Device CRO,Regulatory and Reimbursement Consultancy specialized, in medical device development and market access.
MedPass, a Medical Device CRO, Regulatory and Reimbursement Consultancy, helps companies worldwide bring new technologies to the market by providing a full range of services in medical device development and market access. Key areas of focus include:
- Strategic Consulting
- Clinical Evaluation
- Clinical Operations
- Regulatory Affairs
- EU Reimbursement
- Authorized Representative services
- Legal Representative services
For over 25 years, MedPass has helped to advance the development of breakthrough medical device technologies by offering a broad range of strategic and operational services tailored to meet the needs of our clients.
With such a wide range of Medical Device CRO, Regulatory and Reimbursement services, MedPass is able to offer truly comprehensive assistance across the entire spectrum of the medical device lifecycle. From early identification of regulatory and reimbursement pathways, through clinical trial design, set-up and execution, CE marking, reimbursement and Post Market Clinical Follow-up (PMCF), MedPass experts help companies streamline the development and market access pathways so that physicians and patients can benefit from new technologies as soon as possible.
The European regulatory landscape for medical devices is changing. A new Medical Device Regulation (the MDR) will be implemented in 2020 which will profoundly change the current CE marking system. In the meantime, the regulatory environment for conducting clinical investigations and gaining market approval for new devices in Europe is being tightened. Moreover, country to country differences continue to exist on the national level, particularly with regard to clinical investigations, funding and reimbursement and post market surveillance.
MedPass is uniquely qualified to meet clients’ needs in the current environment. We bring a multilingual and multicultural, diversely skilled and professional team with strong clinical research, regulatory and reimbursement experience. Our consultancy group includes individuals with Competent Authority, Notified Body and healthcare economics credentials. Specially tailored services can be arranged to meet clients’ specific objectives. Emphasis is placed on communication with the client at every stage of project progress.
EU sets high bar for clinical data required for every CE marked product – By John Brosky, Contributing Writer BERLIN – The reform of rules governing the CE mark has shifted requirements for clinical evidence from nearly nothing to far more than most...read more
Since 2015 and the change of the regulation regarding clinical investigation in Spain, Post-Market study should be notified to AEMPS according to RD 1090/2015, Third additional provision, point 3. “The start of clinical research with medical devices bearing CE marking...read more
The Ministry of Health, Welfare and Sport has come to a voluntary agreement with the medical device industry, hospitals and other healthcare organizations to implement a Unique Device Identification (UDI) system for medical devices. The use of this unambiguous...read more