Medical devices

Our team of experienced lawyers provides expert advice across a wide range of legal matters relevant to the industry, ensuring that our clients efficiently navigate the complex regulatory landscape.

Our services include assisting clients in understanding and complying with national and international rules, regulations and industry standards related to medical devices, in vitro diagnostic medical devices, and all those technologies and solutions falling somewhere in between the established categories of devices, including requirements in relation to:

• Clinical evaluations, clinical investigations, safety and performance
• Risk classification, notified body involvement, conformity assessment procedures, declarations of conformity, and CE-marking
• Manufacturing, distribution and import
• Labelling, packaging, and marketing
• Post-market surveillance and reporting requirements