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PRODUCTS SERVICES and INFORMATION Distance Strategy for Class I Devices Quality Management FDA 21 CFR 820 / ISO 13485 / EN 46000
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 |
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
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. 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.mdqaconsultancy.co.uk/authrep.htm or use the Contact details below;
To CONTACT US please; E-mail: mailto:bernardt@mdqaconsultancy.co.uk Tel: + 44 161 980 4310 Fax: + 44 161 903 9787 Request Further Information Form: /feedback.html Thank you for considering Medical Device & QA Consultancy to help you meet your Regulatory Responsibilities |
