Implants, combination products
Placing products of a high risk class (class III and IIb) on the market places high demands on the documented safety of the products and its intended use. Permission to CE mark or approval of the product for the US market requires document control and approved documentation in accordance with relevant regulations
Development and manufacturing must be carried out under controlled conditions at each stage. The documentation shall include documented design control and risk management. The biocompatibility of the product must be assessed.
Prior to placing the product on the market the manufacturing processes and analytical methods must be documented, validated and approved. Manufacturing is to be carried out in accordance with a documented quality system. For combination products of a medical device or pharmaceutical, the combination must be assessed. In the EU combination product containing a pharmaceutical is always assessed by a Notified Body together with an assessment body for pharmaceuticals.