CMC Medical Devices (EU AR)
CMC Medical Devices offers expert regulatory consulting and representation for medical device manufacturers seeking EU and global market access. They specialize in MDR, IVDR compliance, and acting as your EU Authorized Representative (EC REP).
CMC Medical Devices is a leading international consulting firm specializing in regulatory affairs for medical devices. Based in Spain, they provide personalized services to help manufacturers achieve regulatory compliance and market access in various countries, including representation services for the EU (EC REP) and UK (UK RP). They offer comprehensive support for navigating complex regulations such as the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Their expertise includes QMS implementation, EUDAMED registration, and obtaining Free Sale Certificates. CMC Medical Devices acts as a crucial point of contact with local authorities, ensuring smooth communication and continuous compliance for clients outside the EU and UK. With a professional technical team and established offices in key regions like the UK, Switzerland, China, Australia, and the USA, CMC Medical Devices is committed to becoming a reliable partner for medical device manufacturers worldwide. They focus on accelerating product approvals and facilitating business expansion through strategic representation and consultancy services.
About
**Who they are**
CMC Medical Devices (EU AR) is a regulatory consulting and representation firm specializing in medical device market access.
**Expertise & scope**
* Acts as the EU Authorized Representative (EC REP) for medical and in-vitro diagnostic devices, serving as the primary point of contact with EU authorities.
* Provides UK Responsible Person (UKRP) services to ensure compliance with British market regulations post-Brexit.
* Offers Swiss Authorized Representative (CH REP) services, facilitating product entry into the Swiss market.
* Serves as a TGA Sponsor in Australia, managing device registration and post-market compliance with the Therapeutic Goods Administration.
* Functions as a US FDA Agent, assisting foreign manufacturers with FDA requirements for market entry.
* Provides China NMPA (National Medical Products Administration) representation for medical device registration and compliance.
* Assists with the issuance of Free Sale Certificates.
* Offers consulting services for MDR, IVDR, and ISO 13485 compliance.
* Supports EUDAMED registration.
**Reputation / proof points**
* CMC Medical Devices & Drugs SL is located in Spain and is a member of the European Association of Authorized Representatives (E.A.A.R).
* CMC Medical Devices UK is a subsidiary located in London, United Kingdom, and is a member of the Association of Responsible Persons in the UK.
* CMC Medical Devices GmbH is located in Switzerland and cooperates with SWISSMEDIC.
* CMC Medical Devices PTY LTD supports clients as a TGA sponsor in Australia.
* CMC MEDICAL DEVICES LLC has a team with extensive knowledge of FDA regulations.
CMC Medical Devices (EU AR) is a regulatory consulting and representation firm specializing in medical device market access.
**Expertise & scope**
* Acts as the EU Authorized Representative (EC REP) for medical and in-vitro diagnostic devices, serving as the primary point of contact with EU authorities.
* Provides UK Responsible Person (UKRP) services to ensure compliance with British market regulations post-Brexit.
* Offers Swiss Authorized Representative (CH REP) services, facilitating product entry into the Swiss market.
* Serves as a TGA Sponsor in Australia, managing device registration and post-market compliance with the Therapeutic Goods Administration.
* Functions as a US FDA Agent, assisting foreign manufacturers with FDA requirements for market entry.
* Provides China NMPA (National Medical Products Administration) representation for medical device registration and compliance.
* Assists with the issuance of Free Sale Certificates.
* Offers consulting services for MDR, IVDR, and ISO 13485 compliance.
* Supports EUDAMED registration.
**Reputation / proof points**
* CMC Medical Devices & Drugs SL is located in Spain and is a member of the European Association of Authorized Representatives (E.A.A.R).
* CMC Medical Devices UK is a subsidiary located in London, United Kingdom, and is a member of the Association of Responsible Persons in the UK.
* CMC Medical Devices GmbH is located in Switzerland and cooperates with SWISSMEDIC.
* CMC Medical Devices PTY LTD supports clients as a TGA sponsor in Australia.
* CMC MEDICAL DEVICES LLC has a team with extensive knowledge of FDA regulations.
Additional information
CMC Medical Devices emphasizes its role as a direct point of contact with regulatory authorities in each region they cover. They highlight their ability to protect the confidentiality of client documentation, only disclosing technical files to Competent Authorities as legally required. The firm also assists with the issuance of Free Sale Certificates, which are crucial for international product registration and export. Their services are designed to streamline market access by managing regulatory complexities on behalf of manufacturers.
Key Highlights
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Acts as EU Authorized Representative (EC REP) for medical and in-vitro diagnostic devices, ensuring compliance with MDR and IVDR.
Source
“For medical devices and in-vitro diagnostic devices, EU Regulations (MDR and IVDR) require that manufacturers outside the EU designate an european authorized representative based within the EU.”
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Provides UK Responsible Person (UKRP) services for medical devices and IVDs, essential for market access post-Brexit.
Source
“Since Brexit, manufacturers based outside the UK (including EU companies) are required to appoint a UK-based Responsible Person (UK RP) for their medical devices and in vitro diagnostic devices.”
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Offers Swiss Authorized Representative (CH REP) services, crucial for manufacturers marketing devices in Switzerland.
Source
“Since Switzerland and the European Union have not updated the Mutual Recognition Agreement in relation to the MDR and IVDR, manufacturers not based in Switzerland must appoint a Swiss-based Authorized Representative (CH-REP) to market their medical devices and in vitro diagnostic devices in the country.”
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Serves as a TGA Sponsor in Australia, managing device registration and post-market compliance.
Source
“Manufacturers of medical devices and IVDs who are not based in Australia must select a representative in the country, known as an Australian Sponsor or TGA Sponsor.”
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Provides US FDA Agent services for foreign manufacturers of medical devices and IVD products.
Source
“As a foreign manufacturer of medical devices and/or IVD products destined for the United States, you can ensure your path to success in the market by partnering with our exclusive FDA agent services in the USA.”
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Acts as an Authorized Representative in China for foreign manufacturers registering medical products with the NMPA.
Source
“CMC Medical Devices Shanghai Co., Ltd. can represent foreign manufacturers without branches in China as your Authorized Representative in China, to assist in completing the registration of imported medical products with the National Medical Products Administration of China...”
Certifications & Trust Signals
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Member of the European Association of Authorized Representatives (E.A.A.R).
Source
“Spain is a member of the European Union (EU) and is within the European Economic Area (EEA). CMC Medical Devices & Drugs SL, located in Spain, is a member of the European Association of Authorized Representatives (E.A.A.R).”
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Member of the Association of Responsible Persons in the UK.
Source
“As a member of the Association of Responsible Persons in the UK, it has a professional international regulatory team and is qualified to act as the legal entity for manufacturers outside the UK.”
Buyer Snapshot
Best for
- Manufacturers seeking representation in multiple global markets
- Companies needing EU Authorized Representative (EC REP) services
- Firms requiring specialized representation for medical devices and IVDs
How engagement typically works
- Direct regulatory liaison
- Consultative support for compliance
- End-to-end market access facilitation
Typical deliverables
- Appointed EU Authorized Representative
- Registered TGA Sponsor in Australia
- Appointed UK Responsible Person
- Appointed Swiss Authorized Representative
- Appointed US FDA Agent
- Appointed China NMPA Agent
Good to know
- Best when manufacturers are located outside the respective target markets (EU, UK, Switzerland, Australia, USA, China).
HQ:
Spain, ES
Languages:
English, French, Dutch
Timezones:
Europe/Brussels
Status:
listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
BE, NL, FR, DE
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 2,800
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
Spain
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
eudamed_onboarding_support
Additional eu_ar Details
Device Classes Supported
All
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
Spain
Fsca Recall Support
No
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Onboarding involves selecting CMC as the representative, who then acts as the primary point of contact with local authorities and assists in regulatory tasks according to official instructions.
