Demarcation and classification reports
Medicinal product or medical device? The legal framework conditions are entirely different for these two product categories.
Even for combination products, it is necessary to clarify which directive regulates the product. Benefit from our extensive experience in the field of medicinal products and medical devices in the
- preparation of demarcation reports for submission to the authorities or notified bodies
- discussion and decision-making in demarcation issues for your product
Does your medical device meet the fundamental requirements in Europe?
This is proven through the technical documentation for each medical device – regardless of the risk class.
These product dossiers contain all of the technical information about the medical device and a description of its manufacture and development. All data regarding intended use and information on product testing (preclinical and clinical) must be included in the technical documentation. We can create and update your technical documentation, conduct gap analyses and help you with our extensive experience to meet regulatory requirements.
The evaluation of biological safety is a main component of the essential requirements of medical devices. In addition to biocompatibility test results, you can also use and assess data and test results from the literature or clinical application. Depending on the duration of contact and the type of tissue, various biological end points must be addressed. For this reason, the first step is calculating the cumulative duration of contact and the categorisation of your medical device in accordance with ISO 10993-1. For the chemical characterisation, our Laboratory Services department offers the design and implementation of the necessary extraction and migration studies.
We help you to create biological evaluation plans to find strategies, conduct literature research and evaluate all relevant data on biocompatibility in the biological safety report.
Risk analysis is a vital part of the development and certification of medical devices. It compares the benefits of your device with the possible risks. Biological and clinical risks are included in the analysis along with the risks of improper use and technical factors.
We can prepare your risk analysis, especially with regard to biological and clinical safety, thus forming the basis for the successful development and certification of your product.
As a manufacturer, you have several ways of demonstrating the clinical efficacy, safety and clinical benefit of your product: using literature data or your own clinical tests.
Benefit from our regulatory expertise. We are happy to advise you which route is possible, feasible or necessary for your product and coordinate the procedure with you. Our experts conduct extensive literature research and can create both the clinical evaluation and clinical evaluation plan for you, as well as study concepts for clinical trials. PMCF studies are included.
Post-market clinical follow-up (PMCF) plans
One major element in proving the safety and efficacy of a medical device lies in the execution of studies, registers or user surveys of already certified medical devices. These proactive PMCF measures must be planned in compliance with the latest guidance documents and regulatory requirements.
We can support you with the preparation of PMCF plans and the corresponding study plans.
Support with certification
In the early phase of your project, it is important to contact the notified body. If everything is addressed at this point in time, development work is heading in the right direction – for a successful certification of your product.
On request, we can also take over the following activities to build a solid base for your project:
- Contact with the notified bodies
- Preparation and implementation of a scientific consultation
- Support with certification
- Reviewing, optimising and preparation your documentation
- Development of your product