EU REP Where a manufacturer does not have a regis
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Posted On: 02/10/2021 6:29:30 PM
EU REP
Where a manufacturer does not have a registered place of business in the European Community, he shall designate a single European Authorized Representative (EC REP) as required by Article 14.2* of Council Directive 93/42/EEC amended by Directive 2007/47/EC CMC is an authorized EC REP with offices in Spain. The definition of an authorised representative in Regulation 765/2008/EC stablish that: An “authorised representative” acts on behalf on the manufacturer in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation.
Our duties as European Authorized Representative:
Registers your devices with the national Competent Authorities before they are marketed, where applicable.
Acts as your primary contact point for all national Competent Authorities.
Maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
Gives you authorization to place our name and address on your device labels, packaging and Instructions for Use.
Always available to interact between you and the national Competent Authorities.
Responsible for Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities, in cooperation with you and your distributors.
Protects the confidentiality of your documentation. The European Authorized Representative can only show technical documentation to Competent Authorities as required by law.
Monitoring changes to the regulations and communicate you only when is applicable.
Represents you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).
Maintains reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
Notifies or is notified by the Competent Authorities of serious device incidents or FSCA.
Post-market surveillance
Where a manufacturer does not have a registered place of business in the European Community, he shall designate a single European Authorized Representative (EC REP) as required by Article 14.2* of Council Directive 93/42/EEC amended by Directive 2007/47/EC CMC is an authorized EC REP with offices in Spain. The definition of an authorised representative in Regulation 765/2008/EC stablish that: An “authorised representative” acts on behalf on the manufacturer in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation.
Our duties as European Authorized Representative:
Registers your devices with the national Competent Authorities before they are marketed, where applicable.
Acts as your primary contact point for all national Competent Authorities.
Maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
Gives you authorization to place our name and address on your device labels, packaging and Instructions for Use.
Always available to interact between you and the national Competent Authorities.
Responsible for Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities, in cooperation with you and your distributors.
Protects the confidentiality of your documentation. The European Authorized Representative can only show technical documentation to Competent Authorities as required by law.
Monitoring changes to the regulations and communicate you only when is applicable.
Represents you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).
Maintains reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
Notifies or is notified by the Competent Authorities of serious device incidents or FSCA.
Post-market surveillance
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