Medical devices conformity assessment

Depending on the class of the device, a manufacturer may be able to choose between a number of alternative conformity assessment procedures in the assessment of whether a medical device conforms to the essential requirements. Although the rules should be considered in detail in each case, the basic options might be summarised as follows ... 

A manufacturer must apply an appropriate conformity assessment procedure to their device in order to ensure that it complies with the essential requirements, after which they must certify this fact by completing a declaration of conformity. There is usually a choice of conformity assessment procedures open to a manufacturer, depending on a risk-based classification of the class into which the device falls. The two main approaches to conformity assessment are based either on an approved total quality management system audited to ISO 9000 series standard, as customised for medical devices with EN 46 000 series standard, or individual product assessment. 

Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and which is liable to act upon the body with action ancillary to that of the device (e.g. a heparin-coated catheter), the product is classed as a medical device. However, the medicinal product is to be assessed in accordance with the requirements of Directive 75/318/EEC (replaced by 2001/83/EC and updated by 2003/63/EC). A notified body undertaking conformity assessment on a medical device which incorporates a medicinal substance having ancillary action has a responsibility to consult a national medicines agency about the medicinal substance, to verify its safety, quality and usefulness by analogy with the appropriate methods specified in Directive 75/318/EEC. 

A MRA on standards and conformity assessment between Australia and the EC came into effect from 1999, covering eight industry sectors including GMP inspection and batch certification of medicinal products, and conformity assessment of medical devices. 

The ECMRA applies to medical devices manufactured in the EC, Australia and New Zealand. It recognises the competence of designated conformity assessment bodies (CABs) in the EC to undertake conformity assessment of medical devices to Australian regulatory requirements, and the competence of the TGA to undertake assessment of medical devices for compliance with the requirements for certification (CE Marking) for entry onto the EC market. 

Federal Register April 10,1998 (Volume 63, Number 69). Mutual Recognition of the FDA and European Community Member State Conformity Assessment Procedures Pharmaceutical GMP Inspection Reports, Medical Device Quality System Evaluation Reports, and Certain Medical Device Premarket Evaluation Reports. 

Therapeutic Devices Evaluation Committee (TDEC). TDEC is a statutory committee established under the Regulations to the Therapeutic Goods Act, 1989. Its functions are to advise on registration of medical devices. This committee advises on policies cmd priorities rather than the registration of individual devices. Individual device registration is hcmdled within the Medical Devices Section of the Conformity Assessment Branch (CAB) of the TGA. However, unusual or controversial matters are referred to the TDEC. The membership of TDEC reflects the wide range and diversity of therapeutic devices. The committee establishes subcommittees and advisory panels to address particular matters of interest. 

The procedures for conformity assessment are chosen from the various modules and in accordance with the criteria set out in the primary directives. Departure from the procedures is allowed only when the specific circumstances of a directive so warrant. Quality is shown in some of the modules, but a common mistake for some ISO 9000 quality-certified companies is to assume that they can select a module that utilizes ISO 9000 when this is not possible unless the primary directive allows it. There is no mention of ISO 9000 quality in the LVD, EMC, and Machinery directives (see Product Quality versus Factory Quality in Chapter 5). ISO 9000 quality may be necessary for some products (i.e., medical products) under the Medical Device Directive (MDD). 

The European Union Medical Device Directive (and various other national systems) has adopted a review scheme known as the Essential Requirements Checklist. The manufacturer must meet the essential requirements of the Directive, which is a standardized grouping of attributes for medical products. All devices, regardless of classification or conformity assessment route, must prove that the product meets the essential requirements. Where a harmonized standard exists for the product, and the product meets the standard, it is deemed to automatically meet the essential requirements, but for biotextUes, these are few and far between. One notable device-specific standard for a biotextile vascular graft is ISO 7198 First edition 1998-08-01 Cardiovascular implants - Tubular vascular prostheses, which is recognized by FDA. 

This analysis is not exhaustive it is intended to show what should be implemented in the phases of defining the input for the project of a medical device made with resorbable polymers. Importantly, in areas where ISO standards are not present, ASTM standards can still be used even if ISO, ASTM, or both standards are not implemented as for European harmonized standards, they can be used as references, even if the project provides for the assessment of conformity of the MD in the EU regulation context. Of course, the situation must then be explained as part of the TE, and the principle of presumption of conformity cannot be applied. But the use of recognized standards, although not harmonized within the EU context, is possible. 

Initial consideration of these factors gives a basis for further classification (which can be made by the manufacturer himself) and also determines the relevant conformity assessment procedure that must be followed by the manufacturer. Table 9.4 presents the classification of medical devices according to the European regulation— Directive 93/42/ECC (European Commission, 2012). 

An important aspect related to the conformity assessment, is the compilation of technical documentation, also designated the CE technical dossier. The purpose of the technical file of a medical device, in the scope required by the medical devices directive, is to provide the evidence that the manufacturer meets essential requirements concerning the device in question. Although there is no template standard for the technical documentation, basically for all classes of devices it should include ... 

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