European Authorized Representative (EAR) Services
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QualRep Services BV (ISO 9001:2008 registered), a Qserve Group company, provides EU Authorized Representatives services to Non-European Medical device manufacturers and to Cosmetic manufacturers wanting to sell their products within the European Union. Those foreign manufactures must have an Authorized Representative with a physical address in the EU. There are many policies and regulations associated with selling medical devices in the EU, and these are continually being updated and changed, your Authorized Representative must be aware of policy adjustments and regulatory changes that may occur. You cannot simply have a post office box located in the European Union, you are obliged to have a representative that is a registered business with a legitimate EU address. Your European Authorized Representative has the responsibility of observing the manufacturer’s compliance with the conformity assessment procedure set out in the European Directive that applies to your specific product(s). They are also there for vigilant intervention and to handle and file any and all complaints and claims in regard to your product, and must therefore be a specialized and professional company.
March 21, 2010, are the Medical Device Directive 93/42/EEC (MDD) and In Vitro Diagnostic Directive 98/79/EC (IVD), amended by the Directive 2007/47/EC:
New requirements per March 21, 2010!!
- The manufacturers are permitted only to have 1(one) Authorized Representative for a single product code/catalog number within European Union (EU)! Please: read the Medical Device Directive (s) clearly stated in the preamble of this revised directive (14) “…it is necessary to introduce an obligation for such manufacturers to designate an authorized representative for a device. The designation should be effective at least for all devices of the same model.”
- Further you also need to designate an Authorized Representative in case of Clinical Trial activities and when (near) Incidents occur in the Clinical Trial they must be reported to the Local Competent Authority conform the MEDDEV 2.12.1, latest version.
- Authorized Representative MUST be located in European Union (EU)
Why is an European Authorized Representative (EAR) necessary?
The basic need to have an ‘European Authorized Representative’ (EAR) 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. Your EAR muust be located in the EU.
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 services:
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.
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