CE marking a medical device
Team was approached by a small start-up company who needed help developing their novel optical examination device for approval (CE mark) in Europe. The company had significant commercial interest and had secured investor support to achieve the approval as quickly as possible.
Team helped the client establish its classification under the EU Council Directive 93/42/EEC for Medical Devices. It was a Class I (non-sterile) device. We provided a clear development timeline delivering everything the client needed to CE mark on a self-certification basis.
CE marking was achieved within 9 months. The device has been used on 15,000 patients and Team is now developing the next generation product for approval under the EU Medical Device Regulation 2017/745 (MDR).