Quality control medical device markets

Since 1998, all medical devices marketed in Europe (EEA) must bear the CE mark, which signifies conformity to the essential requirements of the MDD. The MDD harmonized the European requirements along with device certification and the inspection procedures for manufacturers to ensure the highest degree of safety and product quality of the medical devices throughout the EC. Most important was the requirement for a full quality assurance system (Annex II of the MDD, 93/42/EEC), which included design controls for new medical device products. This was in line with the ISO 9000 series of standards established for quality systems by the International Organization for Standardization. 

But DSHEA is very different then the standard approval process for drugs and medical devices, and emphasizes the regulatory enforcement of label claims and advertising and marketing issues rather than the efficacy and quality of the supplements themselves. Unlike new drug and medical device applications, controlled clinical trials aren t part of the supplement review process, nor is any FDA inspection of a company s manufacturing facilities or quality control systems. 

Medical Device Amendments required manufacturers with the FDA and follow quality control procedures with some products needing premarket approval and others needing to meet performance standards before marketing. 

The regulatory framework for medical devices begins long before the approval for marketing a product with design controls over the development process and the establishment and maintenance of a suitable Quality System according to 21 CER... 

---