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

 

What makes us different?

• Exclusivity: A customer – an agent. Each customer will be assigned a contact person, a single point of contact who will solve any management or doubt. Our customers have not to deal with different departments of the company (unless the customer requests it), a person will handle everything for you.
• We have extensive experience representing hundreds of medical device companies worldwide.
• Well-trained and qualified staff.
• Saving Costs and time
• Time response: You will always receive a response from your agent in less than 24 hours.
• Results oriented. Our goal is maximizing our customer satisfaction.

 

Cover countries:

Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Grece, Hungary, Ireland Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom, Iceland, Liechtenstein, Norway and Switzerland