Many of my interactions with clients begin when they contact me wishing to gain CE Mark approval for their device to allow them to sell the product into the European Economic Area (EEA).
We generally begin with high-level training to support their understanding and knowledge of the steps required. Then we work together to build their technical file / design dossier and implement an ISO 13485 certified Quality Management System (QMS) that supports the design, manufacture and distribution of their medical device portfolio.
The Irish Competent Authority, HPRA (formerly known as the Irish Medicine’s Board), is responsible for ensuring that medical devices are as safe as possible and that they work as intended. Based on their role as protector of Irish public health and safety, the HPRA website has some very useful content to help educate new innovators on the medical device regulatory requirements. Notified Bodies like NSAI and BSI also maintain excellent medical device guidance on their websites and are a great go-to-resource for medical device entrepreneurs brushing up on the industry requirements.
Here are a number of excellent publicly available resources that can help provide an overview of the steps involved in CE Marking a medical device: