Adapting to the future: TruScreen Advances Toward MDR Compliance.

MDR readiness

As previously reported, the Medical Device Regulation (MDR) is a new global regulatory framework that replaced the Medical Device Directive (MDD) for medical devices being made and/or sold in the European Union after May 2024. The MDR strengthens the safety and efficacy of medical devices, improves patient safety, and enhances transparency and accountability in the medical device industry. The MDR introduces more stringent requirements for manufacturers, including increased clinical evidence requirements, stricter pre-market controls and post-market surveillance requirements, and new rules for economic operators, such as importers and distributors.

TruScreen’s activities in support of the transition to MDR are well underway and the formal application process for MDR certification has commenced. TruScreen has secured the necessary audit by the notified body, TUV SUD Singapore, to seek MDR conformity assessment by May 2024.We are confident, we meet the criteria for compliancy. While costly and effort-consuming, achieving the MDR compliance will ensure that TruScreen technology is competitive and trusted as a leading medical device.

NMPA variation application

TruScreen is in the final stages of completing its Chinese regulatory (NMPA) variation approval submission. This important milestone will grant approval for the latest TruScreen device updates and recertification to the updated NMPA standards. Submission is on track to be completed by the end of August 2023, further strengthening TruScreen’s position in the Chinese market.

Mexico

In January 2023, TruScreen took a significant step to register our technology and device with COFEPRIS.   This will facilitate the regulatory evaluation process to obtain updated approval, allowing TruScreen to enter the public health sector, including government screening programs. Such programs present promising opportunity to expand TruScreen’s marketing reach in Mexico. We expect the COFEPRIS decision by December 2023.

Russia-Kazakhstan certification renewal

All documents required for the certification renewal of TruScreen in Russia and Kazakhstan have been submitted to our distribution partner for submission to local regulators. We are currently waiting for a response from these regulators, which is expected within the next 6 to 12 months.