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* 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 established that: An “authorised representative” acts on behalf of the manufacturer with specified tasks concerning 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.

• Authorises you 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 Authorised Representative can only show technical documentation to Competent Authorities as required by law.

• Monitoring changes to the regulations and communicating with you only when it 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 do not have 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 to maximise 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

The transition period for the United Kingdom to leave the European Union is coming to an end on 31 December 2020. After this date, the UK will be considered a third country if no deal is reached.

It implies that if you are a manufacturer outside of the UK, you need to appoint a UK Responsible Person when your products are placed on the UK market.

Our company with extensive experience in EC Rep services has expanded their offices to assist our clients also offering the service of UK responsible person.

The UK Responsible Person will act on behalf of the manufacturer to carry out specific tasks about the manufacturer’s obligations. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the
Great Britain market. UK Responsible Person will need to be included in product labelling.

All medical devices, including in vitro diagnostic medical devices need to be registered on a new basis, nonetheless, the MHRA has established different grace periods depending on the product classification.

For more information, please do not hesitate to contact us.