Provision of Regulatory Compliance Services MDR & IVDR
Compilation of Technical Files
The new European Regulations MDR 2017/745 & IVDR 2017/746 of the European Union, which replace the directives EEC 93/42, 90/385 and 98/79 and concern medical and in vitro diagnostic medical devices, have already entered into force and require changes in quality management systems of both manufacturers and other economic actors (importers, distributors and healthcare institutes in some cases.)
In addition, new regulation requires significant changes in the technical documentation (technical files) for medical devices.
Aristi Consulting has an expert team with experience in the field of Medical Devices & In Vitro Diagnostic Medical Devices able to provide support on:
preparation of technical documentation for CE certification in accordance with the Medical Device Regulation 2017/745 & In Vitro Device Regulation 2017/746
- gap analysis on technical documentation prepared based on EEC 93/42 and 98/79 in accordance with the requirements of the respective regulations Medical Device Regulation 2017/745 & In Vitro Device Regulation 2017/746
- integration of the new requirements of the Medical Device Regulation 2017/745 & In Vitro Device Regulation 2017/746 in the Quality Management Systems• design, implementation, certification, and support of Quality Management Systems based on the standards ISO9001: 2015 & ISO 13485: 2016
- fulfillment of the regulatory obligations of manufacturers, producers, importers & distributors arising from the regulations Medical Device Regulation 2017/745 & In Vitro Device Regulation 2017/746 (registrations in EUDAMED).
- fulfillment of regulatory obligations of manufacturers, producers, importers & distributors required by the Greek Competent Authority (EOF) for medical devices (production license, registration to the Competent Authority, registration to GREMDIS register, etc.)