Requirements for the admission of medical products made of NiTinol according to the German Medical Products Act (MPG)

Abstract

This paper describes the procedure in placing a medical product on the market. Since June 1998, medical products must have the CE label according to the directive 93/42 EEC. This means that all medical products must fulfill the essential requirements according to Annex I of this directive. Assessments and certifications are made by so‐called Notified Bodies. Medical products are classified into four classes: Classes I, IIa, IIb, and III. There exist 18 classification rules. Biocompatibility of a product must be demonstrated. The standard EN ISO 10993-1 Biological Assessment of Medical Products informs about the type and scope of the tests. The place of application and body contact time are criteria for the tests to be performed. Biocompatibility of NiTinol may be assessed on the basis of clinical data/literature. Clinical suitability of a medical product must also be demonstrated. This can be done by assessing scientific literature or performing clinical tests or by combining both methods. The prerequisites for a clinical test of medical products are outlined among others by Article 20, MPG (General Prerequisites for Clinical Testing). MEDDEV 2.7.1, Evaluation of Clinical Data, represents the guideline for the processing of clinical data. Custom-made products are products intended for a specific patient and manufactured especially for this patient according to a given specification. Custom-made products may be used without a CE label and, hence, are not subjected to assessing by a Notified Body but have to fulfill the essential requirements and must also be documented accordingly. According to the directive 93/42 EEC, the person responsible for placing the product on the market under its own name and CE-label is deemed the manufacturer, even if the product has been manufactured completely by another company.

• Regulatory affairs
• directive 93/42/EEC
• biocompatibility
• certification
• approval