Clinical Evaluation and Clinical Evaluation Report
MDR describes clinical evaluation as a process of continuous collection and assessment of clinical data, culminating in the Clinical Evaluation Report. All available data regarding the performance and safety of the medical device must be critically evaluated.
Diapharm supports the collection and analysis of clinical evaluation and the determination of whether clinical investigations are required. It may be sufficient to submit data from in vitro studies or to conduct a post-market clinical follow-up study (PMCF study). If a full randomized clinical trial (RCT) is necessary, Diapharm manages all steps from concept to completion in collaboration with proven partners.
For in vitro diagnostics, a performance evaluation according to IVDR must be conducted in a similar manner. At IVD, a clinical review may also be required as part of the performance evaluation process.
Clinical Trials
To develop innovative products and stand out in the market, publicly available data is often not enough. With novel approaches, access to suitable, already published clinical data is often difficult or simply not possible.
Generating your own clinical data provides direct evidence that a product is safe and effective. In addition, specific and innovative product features can be demonstrated and documented, paving the way to validate alternative or expanded uses and create new market opportunities.
HÄLSA Pharma GmbH, a subsidiary of Diapharm, is registered as a sponsor for clinical trials and meets all requirements to comprehensively manage clinical trials. Clinical trials by HÄLSA are conducted in accordance with Art. 62 ff MDR in conjunction with Annex XV MDR, pursuant to the requirements of the harmonized standard ISO 14155, and in consideration of the Declaration of Helsinki (WMA Ethical Principles of Medical Research involving Human Subjects).
In addition to regulatory responsibility, HÄLSA also manages project coordination, cooperation with all involved partners, and communication with the notified body and ethics committee.
Medical Devices with Ancillary Medicinal Function
For medical devices with ancillary medicinal effects, Diapharm can provide guidance on compiling the required documentation for the consultation procedure with a national medicines authority or the European Medicines Agency (European Medicines Agency – EMA), addressing pharmaceutical quality, preclinical safety and pharmacology, as well as benefit-risk assessments for the use of the medicinal substance in the medical device.
Biocompatibility Assessment
In the context of clinical evaluation, a biocompatibility assessment in accordance with the harmonized standard ISO 10993 is also required for medical devices. Diapharm collaborates with qualified testing laboratories and institutes — chosen according to the medical device’s risk class—to perform the necessary biocompatibility tests. Test plans are validated with input from a toxicologist. The Biological Evaluation Report (BER) summarizes the results of the biocompatibility assessment.
For so-called substance-based medical devices, further medicinal product regulatory requirements under Annex I, Section 12.2 MDR may apply. Diapharm evaluates the formulations of substance-based medical devices and supports clients in implementing the new General Safety and Performance Requirements (GSPR).
