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Routes to Compliance

 

The Medical Devices Directive - Routes to Compliance

 

When classification has been determined and the essential requirements addressed, devices then require different levels of design and manufacturing control in order to comply with the Directive.


A simplified interpretation of the route, dependant on the class of the device, is provided below.

 

Class l Devices


The least onerous route of conformance is reserved for Class l devices that are not sterile and do not have a measuring function. Class l devices include products such as absorbents, secondary dressings, bandages and incontinence pads. It also includes simple reusable surgical instruments. Under Annex Vll, the manufacturer is required to prepared detailed technical documentation to support a self-declaration of conformity. In addition to meeting the essential requirements, the documentation must contain a description and drawings of the device, the results of risk analysis, design calculations, instructions for use and labelling.


It should be noted that self-declaration of conformity and the affixing of a CE mark on a Class l device does not need any involvement or authorisation by a Notified Body. Users have to rely entirely on the manufacturer’s claims of compliance and therefore are recommended to satisfy themselves that they are dealing with a reputable manufacturer that can demonstrate a track record in manufacturing high quality medical devices. Manufacturers of Class l devices do, however, have to register their products with the Competent Authority. For UK based companies, the MHRA hold this register. The current status of a manufacturer’s registration can be checked online at www.mhra.gov.uk. Users must exercise care, as this in itself is not a guarantee that the product is compliant or of an acceptably high quality.


If the device is sterile, has a measuring function, or falls into any of the other three classifications, the involvement of a Notified Body is mandatory in order to claim compliance with the Directive.

 

Class I Sterile or Measuring Devices


Class l devices that are sterile or have a measuring function require the least intervention by a Notified Body before they can be placed on the market. Manufacturers of these devices must have the aspect of metrology, or the process of manufacturing concerned with securing and maintaining sterile conditions audited within the requirements of Annex lV, V or Vl of the Directive. If compliant, the Notified Body issues a certificate of conformance, which allows the manufacturer to compile a declaration of conformity and apply the CE mark to the product. The CE mark must also be accompanied by the Notified Body’s registration number.

 

Class IIa Devices

 

Class lla devices follow a similar route to Class l Sterile or measuring devices. Class lla devices are generally regarded as medium risk and include products that are more invasive, such as Robinson Healthcare’s Instrapac range of sterile, single use surgical instruments. Following the preparation of technical documentation under Annex Vll, a Notified Body must audit the manufacturer within the requirements of either Annex lV, V or Vl of the Directive.


  • Annex lV – Verification by examination and testing to the relevant standards of every product, or a random sample from each production batch, to the requirements of the Directive and in conformity with the technical documentation.


  • Annex V – Audit of Production Quality Assurance concerning assessment of the quality system and inspection of the manufacturing stage, including securing and maintaining sterile conditions, to relevant standards and the requirements of the Directive, in conformity with the technical documentation.


  • Annex Vl – Audit of Production Quality Assurance concerning assessment of the quality system at final inspection and testing stage for every product or a random sample from each production batch, to relevant standards and the requirements of the Directive, in conformity with the technical documentation.


Whichever route of conformance is selected, if the product is sterile the Notified Body will also audit to sections 3 and 4 of Annex V. If compliant the Notified Body issues a certificate of conformance, a declaration of conformity may be compiled and CE mark and registration number applied to the product.

 

Class IIb and III Devices


The remaining two classes of device both require full Notified Body involvement in order to gain conformity to the Directive. Class llb devices are generally medium risk products that are more complex. For this reason, instead of the manufacturer preparing technical documentation under Annex Vll, it has to be submitted to a Notified Body along with samples of the device for type examination. This is covered by Annex lll and involves a full assessment of the technical information and appropriate testing of sample products. If they meet the requirements, an EC type examination certificate is issued. Assessment then continues as with Class lla products.


Class lll are devices with the highest inherent risk. Products include intra-uterine contraceptive devices and devices that incorporate a substance that would be considered a medicinal product if placed on the market separately, such as Robinson Healthcare Fast Aid plasters with medicated wound pads. The route to conformance is similar to Class lla devices but again more rigorous. The Annex lll type examination must also include clinical evidence derived from clinical trials to support the efficacy and safety of the device. Following the issue of an EC type examination certificate, only the Annex lV and V options may follow, in order that the manufacturing process is audited before a certificate of conformance is issued.


Robinson Healthcare recommends that users request a copy of manufacturers certificates of conformance to confirm that they are current and valid. BSI, Robinson Healthcare’s Notified Body publishes the status of manufacturer’s certification it has issued. This can be found online at www.bsigroup.com.

 

Alternative Route to Conformance


Manufacturers may, if they choose, follow an alternative route to conformance for Class lla, Class llb and Class lll devices. This involves a full quality assurance audit as required by Annex ll of the Directive and covers the design, manufacture and final inspection of the product concerned.


All aspects of the process of bringing the device to market are audited. The Notified Body will also check products for conformity at various stages production, before issuing a certificate of conformance. Additionally for Class lll devices, the full design dossier relating to each product type is examined to ensure it meets the requirements.

 

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