Conducting studies for the regulatory approval of medical devices requires technical aptitude in addition to regulatory experience and expertise. SSS has successfully conducted clinical evaluations for manufacturers of medical devices, including in-vitro diagnostics (IVD) manufacturers. Our experience and know-how covers most types of devices.
Be it a diagnostic kit for cancer prognosis, a high-end imaging device or a medical device combined with a medicinal product – every medical device poses its own particular challenges in the approval process. SSS can help with strategic advice as well as carry out the entire clinical evaluation process on your behalf. Our project managers and clinical research associates have recent experience in performing clinical evaluation programs in the following areas:
Europe’s new Medical Device Regulation (MDR) radically transforms the procedure medical device manufacturers and diagnostic companies must follow to launch their products on the European market. As well as that, manufacturers must maintain compliance throughout the product’s lifecycle. After a three-year transition period ending in May 2020, companies have to provide "sufficient clinical evidence" for the efficacy and safety of medical devices. For in vitro diagnostics, the transition period is five years, ending in May 2022. The new regulations will require clinical evaluation for many products which, until now, could acquire marketing authorisation solely on the basis of comparative studies with equivalent products. What’s more, the new regulation will enforce stricter rules for clinical data. SSS is well prepared for the new MDR and can support you in finding your strategy for the approval process.
