Medical devices brought to the market must display the CE mark. It proves that the product meets requirements of Medical Device Directive 93/42/EEC. The CE mark is based on a technical documentation and on an extensively documented assessment procedure.
Manufacturers have to identify which directives are relevant and whether all criteria are fulfilled. If necessary, a notified body must be consulted for conformity assessment. Then the technical files must be prepared, often accompanied with product tests. This technical documentation includes product description, risk analysis, a list of the relevant directives and harmonized norms, product-accompanying documents, checklist for essential requirements, design and test certification, design and supplier documentation, clinical evaluation, among others. After certification, manufacturers have to affix the mark to their product.
The European legal environment for medical devices is changing. The goal is to create a more transparent and safer system for the user within the EU. A very important step on this road was the release of the Regulation 2017/745/EU on medical devices in May 2017, which will replace the Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implantable medical devices.
The MDR was released in May 2017 but only becomes mandatory in 2020. Manufacturers have time until the end of the transition period. Nevertheless, it is highly recommended to start preparing, now, for the new requirements, since the new requirements according to Annex II and III of the MDR prescribe stricter and more elaborate documentation and proof obligations, for instance in the clinical evaluation.
You can choose us to be your partner when it comes to dealing with notified bodies or product tests and evaluations. You can read our specific services by clicking on the link right side. We can assist you to become compliant with the requirements that you, your medical device and your documentation have to meet.