Medical Devices in Europe do not enter the market until they conform to the European Medical Device Directive. Each country has a standards group, the Competent Authority, which sets the rules for approving devices, and those rules are applied to individual products by the Notified Body.
The Notified Bodies are commercial organisations who audit the paperwork systems that companies must set up to create and produce product (the Quality System), inspect manufacturing facilities (granting ISO 13485Approval), and judge the evidence portfolio (the Technical File) that documents a product’s safety and effectiveness. In the latter case, the review leads to granting of a CE mark, which allows the product to be sold to physicians and to hospitals.
The Technical File is a large and detailed document: ours runs nearly 100 pages and references over fifty standards and nearly 200 supporting documents. We had a half-dozen people and a handful of supporting test facilities in the US, UK, and France engaged for six months to perform the final testing and write the submission.
We kept an aggressive schedule and produced a very high-quality report. It will be some time before it is fully reviewed and we get approval, but this is the milestone that bridges R&D to marketing and sales, transforming a project into a business. ‘Many thanks and a lot of credit to our employees and contractors, our investors and our partners who have have worked together to achieve this inflection point.