Tips on selecting Authorized Representative Services for Medical Device Manufacturers

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PRODUCTS SERVICES and INFORMATION Authorized Representative Class I Self Certification Conformance Routes Design Control Design Dossier Distance Strategy for Class I Devices FDA 510(k) Frequently Asked Questions Hazard Evaluation ISO 9001:2000 Medical Device Safety Own Brand Labelling Post Sales Issues Quality Management FDA 21 CFR 820 / ISO 13485 / EN 46000 Regulatory Affairs Retained Consultancy Review of Safety Technical File Company Profile Home Page Track Record e-mail us LINKS TO OTHER MEDICAL DEVICE SITES List of Competent Authorities UK Competent Authority - Medical Device Agency (MDA) Notified Bodies under Directive 93/42/EEC Download a copy of the Medical Device Directive 93/42/EEC now Summary of the steps to comply with the Medical Device Directive ABHI Association of British Healthcare Industries Medical Device & QA Consultancy's HOME PAGE

Why is an authorized representative necessary? The basic need to have an ‘authorzied representative’ arises because, where a manufacturer is based outside the European Community, the Competent Authorities need to be able to contact an entity or person who is based within the European Community, and who acts on behalf of the manufacturer. There are three terms within the directive which have an impact when the manufacturer is based outside the European Community. These are the ‘authorized representative’, the 'person responsible for placing products on the market’ and the 'importer’. Where manufacturers are based outside the European Community, there is a sound argument for differentiating between the regulatory (including product safety) issues and the marketing issues involved in selling product in Europe. Marketing people generally have sales targets and market share issues to keep them occupied, whilst compliance with the regulatory issues requires a separate and special focus, to keep the Company on the right side of the regulation. Most, but not all, companies do differentiate between the two issues and appoint separate entities to execute the two functions. However, it must be said that the marketing and the regulatory issues can be executed by one entity, if the manufacturer so wishes Selecting an authorized representative The manufacturer has to determine his basic needs before committing to a particular authorized representative. Some authorized representative's offer a very wide range of authorized representative Service. Others offer a service far in excess of that required by the directive. Generally, the more wide ranging the service, the higher the fee. The considerations are whether the manufacturers needs require an authorized representative to provide just the minimum regulatory requirement covering Post Sales Issues or whether additionally Pre Sales Issues such as design of new product, advice on changing regulatory and standards requirements etc need to be included. Typical authorized representative service  As a minimum, any authorized representative service should include involvement in all the Post Sales Issues of ; · Incident Reporting, · Product Recall, · Complaint Handling, and · Post Market Feedback. Additionally, the chosen authorized representative should have the competency to be able to; 'act and to [may] be addressed by authorities and bodies in the Community instead of the manufacturer, with regard to the latter’s obligations under this directive', (see 'amended definition of authorized representative' earlier in this chapter), as and when required, for example; · Registering Class I devices with relevant competent authorities · Notifying Significant Changes to appropriate bodies · Classification or product performance issues · Hold the technical file for inspection by the authorities or be the conduit, by    which the Technical File is delivered to the authorities, as required It is not absolutely necessary for the authorized representative to be totally familiar with the manufacturers particular products, but an authorized representative with experience of a wide range of products, is more likely to be able to serve the manufacturers best interests. An important area where an experienced authorized representative would be of benefit to a manufacturer, is where Class I devices were involved. Because of the Self Certification nature of Class I devices, where the product is not a measuring device and is not supplied sterile, it is important to apply the Classification procedure effectively, because there is no third party verification of either the Technical File content or the appropriateness of the chosen conformance route. In order to provide an effective service, an authorized Representative should also be able to advise a manufacturer on all of the above issues. To be able to be fully effective, the authorized representative should have some means of keeping abreast of current developments and to be aware of new interpretations of existing requirements, as they occur. Can Medical Device & QA Consultancy assist you in your search for a reliable and effective Authorized Representative Service? If you have any questions that are not answered in the above text, or if you need a quotation for Authorized Representative Services, please follow this Link http://www.mdqaservices.com/authrep.htm or use the Contact details below; To CONTACT US please; E-mail: mailto: info@mdqaservices.com Tel: + 44 161 980 4310 Fax: + 44 161 903 9787 Request Further Information: info@mdqa.co.uk Thank you for considering Medical Device & QA Consultancy to help you meet your Regulatory Responsibilities