Genoa, December 13th, 2022 – All the companies involved in the production and commercialization of medical devices have been struggling in the latest 2-3 years to achieve the migration of their products and processes from the compliance to the MDD (Medical Devices Directive 93/42/EEC) to new MDR Regulation.
MDR CE marking pays greater attention to technical documentation, including clinical evaluation, post-marketing clinical follow-up and traceability of devices in the supply chain, and requires a very rich documentation package, reflecting rigorous testing procedures and quality standard.