Quality

The European Authorized Representative for CE Certified Medical Devices Manufacturers

- Sanjay Shah

All Manufacturers of Medical Devices planning to export to European Union ( EU ) countries are required to obtain CE marking for their Products. In the last issue, we had discussed the requirement for appointing an Authorised European Union Representative ( E.A.R. ) as per Medical Device Directive MDD/93/42 . In this issue, we go further to more details about the essential duties of E.A.R. and also important issues related to the agreement with E.A.R.

Following are Essential Duties required: 

• Authorization to place its name, address, phone number on device labels, product inserts etc. 

• Acting as primary contact point for the EU Authorities. 

• Registering of Risk and Technical File details for Class I devices with the Authorities before they are marketed. 

• Keeping Technical File documentation ready and available for the European Competent Authorities. 

• Protecting documentation confidentiality because they are authorized to show them to the Competent Authorities only. 

• Notification of serious device incidents to the Competent Authorities. 

Additional services an experienced A. R. provides are: 

• Assistance with technical file documentation including examples of procedures 

• Simplification of the Risk Analysis 

• Co-signing of the Declaration of Conformity 

• Annual review of your technical file 

• Notification of changes and amendments to the Medical Device Directive that affect your device(s) 

• An exhaustive web-site giving details about Directives, changes or proposed changes and changing scenario about the devices manufactured by the Company, for example refer web-site www.obelis.com to understand exhaustive services provided by European Authorized Representatives. 

• Use of their office for administrative work and meeting place during visit of Manufacturer to the city of E.A.R.’s office in EU Country 

Device Manufacturer, when appointing, E.A.R. has to provide details to them, important ones are noted as follows: 

• Device compliance with the Medical Device Directive requirements 

• Placing of your technical documentation in its trust 

• Immediate notification of device incidents 

• Product Liability Insurance coverage that includes the EU 

• Indemnification of product liability 

The E.A.R. requires that Device Manufacturer places Technical File copy with them and further requires that the same should be up-dated as when changes are carried out. 

This enables the Authorized Representative to respond to inquires from the Competent Authorities within an allocated time period. 

Other Directives applicable during the Device export to EU Countries include the product liability directive. 

The Product Liability directive includes A.E.R. and hence the product liability insurance requirements are insisted upon by the E.A.R. 

The product liability directive refers to any entity placing its name on the device. The medical device directive requires that the manufacturer plus the Authorized Representative names be printed on the device label, with the result both parties are held liable. To prevent duplication of liability insurance for the same device the Authorized Representative becomes an additional insured under the manufacturer’s worldwide policy.

The Agreement with EU Authorized representative is a legal document and terms there of have to be agreed upon but important amongst them affecting Device Manufacturer relates to product liability inclusion and responsibilities of Device Manufacturer. 

Since the Authorized Representative is subject to EU law and the device manufacturer resides outside the EU Legal Jurisdiction may decide not to cooperate with the EU authorities. To minimize the Authorized Representative’s exposure of being on the receiving end of a manufacturer’s liabilities, the penalty clauses provide recourse.

On termination of Agreement with Authorized Representative the Authorized Representative’s name remains on the devices already sold and still in use, resulting in the continuation of some obligations even after termination of the agreement.

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