MolecularHealth GmbH, the European arm of MolecularHealth, announced today that it formally started the registration of its proprietary oncology treatment decision support software as a medical device with DIMDI, the German Institute of Medical Documentation and Information. Accredited medical devices gain CE marking, and thus provide medical device and technology market access to EEA 30 and MRA countries, with a population of almost 500 million.
Medical device accreditation indicates compliance of MolecularHealth’s oncology treatment decision support software and services with the applying requirements of the EU Medical Device Directive 93/42/EEC issued by the European Commission and passed into national legislation of each EU member state. MolecularHealth GmbH has implemented a quality management system according to ISO 13485 and applies the international standards IEC 62366 (usability), IS0 14971 (risk management), and IEC 62304 (software lifecycle).
"To successfully enter the market in Europe, gaining accreditation as medical device is a requirement, and we are delighted to be fully compliant with the EU Medical Device Directive,” said Stephan Brock, CEO, European Division of MolecularHealth. “We believe MolecularHealth’s oncology treatment decision support software is the first to be granted accreditation as medical device in Germany—and possibly across Europe. The standards associated with the EU Medical Device Directive are high, and we are very proud to have achieved this milestone for the company." After eight years of development by a multidisciplinary team of doctors, scientists and IT experts in Heidelberg, Germany, MolecularHealth is preparing for the commercial launch of its genetic diagnostic platform in the United States and Europe. The company, backed by Dietmar Hopp, co-founder and former chairman and CEO of SAP, offers an end-to-end service that walks patients and their healthcare providers through the molecular diagnostic process—collecting tumor samples, analyzing the samples, and interpreting the results using a unique analytics platform—all to generate safer and more targeted cancer treatment choices. As part of its offering, MolecularHealth will provide patients, oncologists and pathologists with complete logistical support and help navigating insurance reimbursement for recommended treatments.