Classification Report

The classification report aims to qualify and classify a product in either a medical device, in vitro diagnostics and/or medicinal product definitions according to the applicable regulatory framework. This service is key in early phases of product development to understand the category and class of the product that will ultimately define the regulatory requirements though all the lifecycle. This service is offered to startups, pharma, biotech, med-tech companies developing an in vitro diagnostics, medical devices, combination products, borderline products, ATMPs and/or medicinal products that aim to qualify and classify their product according to current European standards. The Classification Report will determine the categorisation and the classification of the product considering the applicable regulatory framework. Before the start of the project a kick off meeting will be conducted with EIC beneficiaries. Upon completion and delivery of the report, EIC beneficiaries will have a discussion meeting with regulatory experts to discuss any doubts or questions.