About us

CMC MEDICAL DEVICES & DRUGS, S.L. is a leading international consulting firm that specialises in regulatory affairs and focuses on medical devices. Our headquarters in Spain allows us to operate from Europe to the rest of the world, we also have local representation in many other countries such as China, India, Argentina, the USA, and Brazil. We represent companies around the world, being our priority, to results and customer satisfaction.

Our Mission

Help our customers overcome limits and cross borders.

Contribute to make the medical devices market more valuable and available.


Our Vision

Focus on needs of our clients: We provide customized services in order to achieve the best possible solution for every customer.

We achieve profitable growth for our clients by implementing diversified business models and opening markets.

To create value and make a difference.

Work efficiently and act with urgency.

CMC offers its clients comprehensive, flexible and cost-effective solutions.


Our Value

 To be a company trusted by customers and society, a company fully responsible for its actions.


Member Of:




What makes us different?




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.



Switzerland is not part of the European Union, but historically trade relations have been straightforward with multiple bilateral treaties and agreements.

However, this has recently changed. Switzerland and the EU have not renewed the mutual recognition agreement (MRA) governing CE-marked products. This has implications for medical devices. From 26 May 2021, European manufacturers who want to place their medical devices on the Swiss market have to meet additional requirements: European manufacturers who want to place a medical device on the Swiss market have to appoint an Authorised Representative domiciled in Switzerland or CH-REP. The details of this representative in addition to the "CH-Rep" symbol must be included in the product labelling.

We at CMC have expanded our offices to be able to continue to support our customers in the Swiss market.

As CH-Rep, we will be the contact point for the Swiss authorities (Swissmedic). We will act on behalf of the manufacturer to carry out specific tasks about their obligations.

We put all our expertise at the disposal of our clients to guide them through this process.

The Swiss regulations have provided different deadlines for all actors to adapt to these changes.

CMC Medical Devices will help you to be ready so that you will not encounter any obstacles to marketing your products in Switzerland.

You can click on the map below for more information, or you can also contact us. We will be happy to assist you.



Free sale Certificates

What is it? The Certificate of Free Sale or FSC is an international document used to export medical devices and IVD products. It indicates that your products are marketed in Europe and can be freely sold with no limits to their exportation.

The FSC is required to export medical devices and IVD products in certain countries. This document acts as proof that your goods meet European regulations and are eligible for export. This certificate is used to register or renew the registration in non-European countries.

Not all FSCs have the same acceptance rate by the competent authorities in some importing countries. It is important that your FSC is issued by a reference country. Spain is one of the so-called “reference countries” and all our certificates have always been admitted, making new markets available to our customers.

For further information, please contact us at:



CMC we will guide you through the CE road map for medical and in vitro diagnostic devices under the new regulations (MDR 745/2017 & IVDR 746/2017) in order to affix the CE Mark on your device.


Clinical Evaluation is the final validation of a medical device to confirm that it performs as intended and can safely be used in patients in accordance with its instructions for use. According to the regulation, to fully comply with MDR 2017/745 and IVDR 2017/746, it is important to follow the requirements defined in ISO 20916:20219 for In Vitro Diagnostic devices and ISO 14155 for medical devices. It mainly focuses on clinical research services, clinical trial data management, including statistical analysis, and all needed data to prove the device's safety. Manufacturers based outside the European Union, if you are planning to go into the European market, you must have clinical trials performed in Europe complying with the new regulations MDR 2017/745 and IVDR 2017/746. CMC has been working in the medical devices and IVDs field for a decade; our team has more than 15 years of experience; we are specialised in regulatory compliance; and we can help you meet all European requirements for your clinical evaluation performance study. We provide a wide range of professional services to assist medical device companies in bringing new devices to market. CMC can design compliant clinical studies for manufacturers based on the most comprehensive regulatory guidance documents. The current clinical guidance documents in the EU region are as follows:


  • l  ISO 14155-2020 
  • l  MEDDEV 2.7/4
  • l  MEDDEV 2.7/2 Rev 2 
  • l  MDCG 2021-20 MDCG 
  • l  2021-08 MDR 
  • l  ISO 20916:2019
  • l  MDCG 2021-2 - COVID-19 

CMC can also be your EU legal representative for medical devices and IVD clinical trials. Does your medical device lack clinical data? We can help determine how to efficiently close those gaps and support your clinical investigations.


According to Regulation (EC) 1223/2009, it is mandatory for manufacturers who do not have headquarters in the EU to designate a Responsible Person (RP) to be able to market Cosmetic Products in the EU. The Responsible Person is fully responsible for product safety and legal compliance.

Regulation (EC) 1223/2009 establishes the standards that all Cosmetic Products marketed in the European Union (EU) must comply with in order to ensure the functioning of the internal market and achieving a high level of protection of human health.

All Cosmetic Products marketed in the European Union must undergo a Safety Assessment carried out by a qualified person. A Cosmetic Product Safety Report (CPSR) must be completed and included in the Product Information File (PIF).

As Responsible Person, CMC can assist the manufacturer to carry out specific tasks in relation to its obligations. This includes writing, compiling and maintaining the Product Information File (PIF), conducting the Cosmetic Product Safety Report (CPSR), registering the Cosmetic Product in the CPNP Cosmetic Product Notification Postal, as well as assist the manufacturer in preparing Good Manufacturing Practices to document and regulate the production, control, storage and dispatch of cosmetic products.

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Welcome to CMC


Do not hesitate to contact us for any questions, prices or timelines in the registration process.