Before continuing with the focus on the product, one needs to consider the company or companies that will be developing, potentially producing and ultimately commercialising this product.
The expertise required by developers of IVD medical devices is significant. In addition to the general design and engineering expertise which is required of any industrial products company. IVD medical device developers also require risk management, quality management, medical and regulatory compliance expertise. Read through Article 10 and consider whether your company has or can recruit the expertise needed to develop and gain approval for an IVD medical device? Does it also have the capabilities to manufacturer, distribute and support the intended users in multiple countries? Consider whether some or maybe even all of these activities should be sub-contracted to specialists.
Deliverables for demonstrating compliance:
(1) The Design and Manufacturing processes (Article 10, 1),
(2) The Risk Management process (Article 10, 2),
(3) The Performance Evaluation process (Article 10, 3),
(4) The technical documentation development and maintenance process, including the UDI and the EU declaration of conformity (Article 10, 4-7),
(5) The Quality Management System (Article 10, 8),
(6) The Post Market Surveillance planning process (Article 10, 9),
(7) The labelling development process, including producing language translations (Article 10, 10),
(8) The corrective action and recall process (Article 10, 11),
(9) The vigilance process, including reporting of incidents and field safety corrective actions (Article 10, 12),
(10) The regulatory authority interaction process (Article 10, 13),
(11) The legal liability and damage compensation process (Article 10, 15)
(12) One or more persons overseeing the regulatory compliance (Article 15),
(13) Access to technical, safety (risk), performance, quality and regulatory expertise.