WHAT IS A MEDTECH CRO?

A MedTech CRO is a company that provides contract research organization services to aid medical device manufacturers in the entire process, from patent to post-market support. By offering expert consulting, quality assurance, medical device regulatory affairs, and clinical investigation expertise, it serves as the optimal partner for the development of medical technologies.

WHAT IS AN IVD CRO?

An IVD CRO is a contract research organization that specializes in supporting IVD manufacturers and laboratories from the In-Vitro Diagnostics patent to the post-market phase. An IVD CRO provides quality assurance and regulatory and clinical performance expertise to be the optimal partner for the development of in-vitro diagnostics technologies and in-house testing.

MDx, YOUR MEDTECH-IVD CRO

As a MedTech CRO in Europe, MDx offers complete life-cycle expert support for your medical device and in-vitro diagnostic projects. The expert team designs an optimal plan for your CE Mark strategy to save time and resources in your medical device and diagnostics innovation pipeline. Covering the quality support in your QMS, the regulatory affairs consulting services for the development of Technical Documentation, and the medical writing for Clinical Evaluation and IVD Performance Evaluation and the Clinical Research Operations management under the EU MDR 2017/745 and EU IVDR 2017/746.

MEDTECH CRO SERVICES

THE IMPACT OF EU MDR AND EU IVDR ON THE ADOPTION OF MEDICAL TECHNOLOGY IN EUROPE

The EU Medical Device Regulation (MDR) 2017/745 and the EU In Vitro Diagnostic Regulation (IVDR) 2017/746 came into effect on May 26, 2021 and 2022, respectively. These new European regulations bring significant changes for MedTech manufacturers, including expanded product coverage, alignment with European and international regulations, reclassification based on risk, stricter clinical evidence requirements, heightened scrutiny and involvement of Notified Bodies, increased focus on post-market surveillance, and updated quality management system (QMS) requirements for medical devices and in vitro diagnostics manufacturers.

TEAM CREDENTIALS

THE DIFFERENCE BETWEEN CLINICAL TRIALS, CLINICAL INVESTIGATIONS AND CLINICAL PERFORMANCE STUDIES

• EU MDR 2017/745 defines clinical investigation as a systematic study involving human subjects to evaluate the safety or performance of a medical device;
• EU IVDR 2017/746 defines clinical performance study as a study done to establish or confirm the clinical performance of a device, which is the ability of a device to produce results that are related to a particular clinical condition, physiological or pathological process or state, and the target population and intended user;
• ICH E6 defines clinical trial as an investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

MEDTECH CRO PRODUCT AREAS