Medical devices

When placing a medical device on the market the manufacturer must have demonstrated through the use of appropriate conformity assessment procedures that the device complies with the relevant essential requirements covering safety and performance. Generally, from a clinical perspective, it is expected that the manufacturer has demonstrated the device achieves its intended performance during normal conditions of use and that the known and foreseeable risks, and any adverse events, are minimised and acceptable when weighed against the benefits of the intended performance, and that any claims made about the device’s performance and safety are supported by suitable evidence. According to Directive 93/42/EEC and 2007/47/EC and EC guidelines on medical devices (MEDDEV.2.7.1 Rev 4 from June 2016) demonstration of conformity must include a clinical evaluation in accordance with Annex X. A clinical evaluation should be thorough and objective, with the intention of demonstrating valid clinical evidence of the safety and performance of the device. Clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device.

In addition, for medical devices, the biological safety of a product has to be evaluated in view of the harmonized standard EN ISO 1 0993-1 “Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process” . This standard describes the general principles governing the biological evaluation of medical devices within a risk management process and the assessment of the biological safety of the medical device. It also classifies medical devices regarding their nature of body contact and contact duration. The purpose of a biological evaluation of a medical device is to ensure – from a biological and toxicological perspective – that the device is safe for the user.

We provide support primarily for the registration of „substance-based“ medical devices in accordance with the actual regulatory requirements (Council Directive 93/42/EEC, Directive 2007/47/EC, MEDDEV 2.7.1, ISO 10993-1).  We prepare reports on biological and clinical evaluation of medical devices to demonstrate that the device complies with the relevant essential requirements covering safety and performance. The documentation on the medical device will be compiled on the basis of your own data or clinical studies, as well as a literature search.