As of 26.05.2021, the 93/42/EC Medical Device Directive (MDD), which is based on the CE certification processes for Medical Device Manufacturers, was abolished by the European Commission and replaced by the (EU) 2017/745 Medical Device Regulation (MDR).
The new Regulation has brought with it many new studies or changed the existing studies, especially for clinical safety and performance, such as Clinical Research, Post-Market Clinical Follow-up, Critical Reporting for Medical Devices produced by Medical Device Manufacturers.
CONFORMED, with its 13 Years of Medical Device Certification Industry Experience and Expert Staff, has adopted the principle of supporting the Medical Device Manufacturers in this process, as in every process.