IVDR Compliance
The regulatory framework for in vitro diagnostic medical devices, governed by Regulation (EU) 2017/746, is constantly evolving and being further defined. For manufacturers, producers, authorized representatives, distributors, and importers, we offer a range of services to support your company along the most appropriate compliance path.
We will review the available documentation and develop a concrete program detailing the necessary activities, resources, and timelines to achieve the goal.
Preparation of technical documentation: Targeted consulting for the review and/or preparation of the technical documentation required by Regulation (EU) 2017/746, in collaboration with company representatives or independently in case of full outsourcing. We analyze the available documentation to ensure it is clear, complete, and always easily accessible.
Regulatory strategy development: Consulting to ensure proper classification and to define the best certification strategy, identifying the tests required to complete the technical documentation in support of your IVD.
Support in the preparation of the risk management file according to ISO 14971: Consulting for planning the activities needed to review or produce the risk management document in compliance with international standards ISO 14971:2019 and ISO/TR 24971:2020, or to train your team and support them in the development process.
Assistance in registering Economic Operators and IVDs: We support companies in the proper registration on the EUDAMED portal and provide standard procedures and training, enabling them to operate independently and stay up to date with future changes and updates.
Support in the selection of the Notified Body and interactions with Competent Authorities: We assist companies in selecting a suitable Notified Body and in managing interactions with both the Notified Body and Competent Authorities, defining together—when necessary—the best approach to establish a constructive dialogue.
Authorized Representative, Distributor and Importer: These are economic operators with specific responsibilities and obligations. We provide consulting to help them comply with the applicable requirements.
Why choose FTR ADVISOR? Because we take into account the company’s context and available resources when designing a regulatory compliance plan.