Certification for Medical Devices

• Published in: Biomedical Devices p. 1
• Main Authors: Paganelli, Corrado, Bindi, Marino, Laffranchi, Laura, Dalessandri, Domenico, Salgarello, Stefano, Fiorentino, Antonio, Vatri, Giuseppe, Hensten, Arne
• Format: Book Chapter
• Language: English
• Published: United States John Wiley & Sons 2017; John Wiley & Sons, Incorporated; John Wiley & Sons, Inc
• Subjects: Biochemistry, Biology & Biotechnology; BIOLOGY, LIFE SCIENCES; Biotechnology; certification; clinical evaluation; MECHANICAL ENGINEERING & MATERIALS; medical devices
• ISBN: 9781118478929; 1118478924
• DOI: 10.1002/9781119267034.ch7

Certification of medical devices can be divided in the fields of materials (to be used directly by patients or by clinicians) and devices (including custom made medical devices). The materials are dependent on intrinsic characteristics and properties that can be tested in a lab with significant preview of clinical performance. The medical devices are placed in activity by or according to instructions by the clinician. Furthermore, the materials may be used in a custom‐made medical device made by the clinician, while medical device is performing a function. Dental materials are a good example of such a difference: an elastomeric mass is a product to be used directly by the clinician in the mouth of the patient, but with a deep influence by manipulation and insertion. Even more relevant is alginate impression material or alloys to be cast by dental technician with accurate proportion of components and impossible detection afterwards if the final product is deficient because of the poor quality of original ingredients or outcome misuse, with even infinite value for patient behavior. There are differences in the evolution and intended aim of the regional institutions. So the agreement between FDA and EU medical device directive (MDD) offices has become effective and the technical description required by manufacturers is equivalent, nevertheless EU is evolving toward the request to “Notified Bodies” to increase deep and frequent analysis and control by means of new directives addendum, while FDA (US Government Agency) is increasing internal controls with intensive use of references and previous clinical experience. Similarly, EU is asking to insert more controls in the revision and annual recertification system, sometimes inclusive of quality assurance system, while FDA is devolving more relevance to its auditing in order to verify GMP in action. Also, MERCOSUR is evolving in line with FDA , so the global perspective is inducing to conceive the proposal of new medical devices targeting the market, in particular as for as registration and clinical evaluation both time and costs. While standards and technical norms in some fields (e.g., biocompatibility testing and re‐sterilization) are at a good level and allow a satisfactory level of confidence in most of the applications, clinical evaluation of most medical devices are still in a primordial status of harmonization and standardization. Dynamic and flexible aspects of trade, regulatory rules and surveillance postmarket are the main characteristics of the global perspective of medical devices around the world.