Regulatory Consulting (medical devices)
Small companies or start-ups in particular often have the most innovative ideas and products. Unfortunately, marketing a new product is not the easiest thing to do, neither in the US nor in Europe. Experts recommend starting with the European market, as European market access will support FDA clearance.
When you plan to market a medical device in Europe, you will need a CE mark. The CE mark may only be applied for after the conformity assessment, which confirms that your device is safe and performs well. However, this is not the only requirement. There are some additional regulations which must be observed, mainly regarding technical documentation and quality and risk management. Europe is currently transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), with all medical device manufacturers having to observe the new regulations from 2020 at the latest. Now may be a good time to put a new device on the European market, since you can start by using the new regulations.
We can advise on strategies on how you should set up your documentation, how to establish risk and quality management and whether or not you need clinical studies to obtain clinical data. If a clinical study is needed, we will advise on cost-efficient options and carry out the regulatory submission for you for approval. If, however, an equivalent device is on the market, you may be able to use clinical data from literature instead of conducting a clinical study. This question is assessed in a clinical evaluation, which is required for every medical device. For all requirements, we can help you choose the most reasonable way to plan your budget.
+49 9872 9699027
+49 9872 9699029