Notified bodies

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

As referred to above, most of the modules involve the intervention of a third party, the so-called notified bodies. These bodies are designated by Member States as being competent to carry out the certification tasks for which they are notified. As a precondition for their notification they must fulfil the minimum criteria which are set out in the relevant directives. These conditions vary from independence, impartiality and professional integrity, to technical competence, possession of or access to necessary facilities and to liability insurance. Once notified, the Commission publishes a list of all notified bodies in the Official Journal, It is worth noting that there is free competition between notified bodies and that manufacturers can make their own choice from all notified bodies notified within the European Union. 

A section related to materials sets out, apart from general requirements, that compliance with the material specifications of the directive can be achieved in one of the following forms by using materials which comply to harmonised standards, by using materials covered by a European approval of materials, a subject which will be explained further on, and by a particular material appraisal carried out by the notified body. 

As a precondition for notification of the recognised third party organisations the Member States shall apply the same criteria as for notified bodies and the Commission shall, as in the case of notified bodies, publish the references of theses organisations in the Official Journal of the European Communities. 

Where conformity assessment involves intervention of third party, that task is normally carried out by the notified body. The pressure equipment directive enables in addition the national authorities to authorise in their territory user inspectorates for the carrying out of conformity assessment procedures which relate to product verification. These inspectorates shall act exclusively on behalf of the group of which they are part. The placing on the market and putting into service of equipment which has undergone such assessment is however limited to the territory of the authorising Member State and to those Member States which have also proceeded to such authorisation. The equipment concerned shall therefore not bear the CE-marking. 

The user inspectorate must fulfil the same technical criteria as the notified body. In addition, it must be organisationally identifiable and demonstrate its impartiality. It must not engage in any activities that might conflict with its independence of judgement and integrity. Given that the authorisation of user inspectorates to carry out conformity assessment is an innovation for technical harmonisation at Union level, the Commission shall monitor the application of this measure and evaluate its effects three years after the coming into force of the directive. 

The basic mark is illustrated in Eigure 9.2. Depending on the type of product, it may be accompanied by the identification number of the Notified Body responsible for performing specified conformity assessment tasks (see Chapter 10). 

Different conformity assessment options are available, depending on the type of device and the level of associated risk. For lotv-risk devices, the manufacturer can make a declaration of conformity based solely on self-assessment, without the need for the involvement of a Notified Body. For all other devices Notified Bodies are required to perform one or more of the tasks outlined in Table 10.2. HIV and hepatitis tests and blood grouping tests represent the highest risk devices, as they are critical to ensuring the safety of blood and blood products. For example, a defective HIV test device could result in widespread infection in an unsuspecting population, whereas the detrimental effects ofan AIMD or a Class III device failure will just be confined to the individuals treated by the device. At this end of the risk spectrum. Notified Bodies are required to verify the applied quality system, the specific device design, and the... 

The purpose of all the conformity assessment procedures is to ensure that the device as designed and as subsequently manufactured will meet the essential requirements. For most devices where Notified Body involvement is required, the manufacturer may choose between the strategies of relying on the application of appropriate quality systems or independent testing to demonstrate this. 

Placing of Devices on the Market in the EU 197 Table 10.2 Certification activities of Notified Bodies. 

The EC type-examination is the process that the manufacturer may use to obtain independent verification that a design conforms to essential requirements, when a certified QA system has not been applied to the design process. The manufacturer must submit an application to the notified body, accompanied by documentation on the device design and physical samples of the device. The Notified Body examines the... 

Production QA is the process whereby the manufacturer adopts a quality system for the manufacture and final inspection of a device. ISO 13485 may also be used as the model in these circumstances, as the design and development elements may be omitted from this standard. The manufacturer must lodge an application with a Notified Body to have his/her system examined. The application must be accompanied by documentation on the quality system and information on any relevant EC type-examined devices. 

EC verification provides an alternative to the model of establishing a certified production QA system. Independent testing of either all devices, or a statistically representative sample of each batch, is conducted by or on behalf of the Notified Body, which then issues a certificate of conformity for the tests conducted. This is not a popular option due to the costs involved. The procedure is not capable of providing adequate assurance as to the sterility of devices. Instead, an assurance of sterility must be based on the application of a production QA system to the sterilisation process. 

Product QA is the process whereby the manufacturer applies to a Notified Body to have his/her quality system for final inspection audited and certified. EN 46003 may be used as the harmonised standard for this model. 

For low-risk devices the manufacturer may make a declaration of conformity with the essential requirements on the basis of a self-assessment, without any input from a Notified Body. In the case of Clas s I devices that are sterile or have a measuring function. Notified Body involvement is required, to provide assurance as to the effectiveness of the sterilisation process or the meteorological traceability of values as appropriate. 

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED ... 

Data relating to device certifications issued by Notified Bodies... 

The FDA are allowed 90 days to review a Traditional or Abbreviated 510(k) notification, and just 30 days for a Special 510(k). With the introduction of the Medical Device User Fee and Modernization Act of2002, provision was made for the participation of third-party organisations in the review process. This represents a partial adoption of the concept of Notified Bodies, which prevails in Europe. The FDA have accredited a number of commercial organisations to conduct primary 510(k) reviews of670 types of device. The FDA must then give a final determination within 30 days of receipt of the recommendation of a third-party reviewer. Because they are commercial, third-party reviewers will seek to offer faster review times in return for their review fee. If using a third-party reviewer, the FDA user fee does not apply. The outcome of a successful 510(k) notification is a letter from the FDA clearing the device for commercial sale. 

High (III) Specific Clinical Investigations 60 days for approval by CA Required Notified Body certification... 

Moderate (II) Review of existing dinical data 60 days for approval by CA Not required, if can be used Notified Body involvement... 

An overview is presented of the CE marking requirements for manufacturers of medical devices, the role of EU Notified Bodies and third party approval and the provision of relevant data to the manufacturers of medical devices. 

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. 

For all products in Classes Ila, lib and III, and AIMDs, a full quality assurance system, audited periodically by a notified body (Annex II of the MDD), which includes examination and certification by the notified body of the design dossier of each product covered. The manufacturer must keep documentation on the quality system and the design dossier of each product plus other documentation. The quality system obligations include post-marketing and vigilance aspects. Compliance with Annex II may be achieved (this is not mandatory but is invariably adopted voluntarily) by compliance with the EN 29000... 

For products in Classes Ila, lib and III, and AIMDs, examination and certification by a notified body of a specimen product (t)q)e examination Aimex III of the MDD) coupled with a varying degree (partially restricted by product class) of product or production quality assurance (MDD Annexes IV, V and VI), which ensures that the manufacturing process produces products that conform to the certified t)q)e and might involve a quality system for manufacture and final inspection (Annex V), or a quahty system for final inspection and testing (Annex VI). 

For products in Class I, the manufacturer must have specified technical documentation on the design of the product showing that it conforms to the essential requirements manufacturing aspects are not covered and a notified body is not involved imless there is a measuring function and/or the product is sterilised. (Annex VII EC declaration of conformity.)... 

The primary consideration of a clinical investigation of a device is assessment verification of the manufacturer s claims for the technical performance of the device. Safety considerations are, nevertheless, relevant in that the clinical investigation should determine and assess any undesirable adverse effects, but the main thrust of the clinical evaluation, and in particular of the conformity assessment by a notified body or the manufacturer to permit marketing, is on technical performance rather than a complete evaluation of safety. It is an essential requirement for marketed devices that [A]ny undesirable side-effect must constitute an acceptable risk when weighed against the performances intended. ... 

All devices other than those covered by Annex II are subject to the EC Declaration of Conformity procedure (Annex III), which does not involve the intervention of a notified body, but which includes supplementary requirements for devices for self-testing, which does involve a notified body (Annex III). 

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