AF Pharma Service: Medical Device Regulations Specialists

EU Authorized Representative (CE Rep) | UK Responsible Person (UKRP) | US Agent | Importers

AF Pharma Service is the solution for medical device registration in the EU, UK y US.

We act as EU Authorized Representative, UK Responsible Person (UKRP) and FDA US Agent.

AF Pharma Service is your trusted partner for achieving medical device regulations compliance and accessing the European Union (EU), United States (US), and United Kingdom (UK) markets for medical devices, cosmetics, machinery, and nutraceuticals. As experts in the field, we offer a range of services including acting as EU Authorized Representatives, EU Importers, UK Responsible Persons (UKRP), UK Importers, and FDA US Agents.

Our diverse and dynamic consultant team brings extensive expertise in the EU, UK, and US medical device regulations, allowing us to provide comprehensive support tailored to your specific needs. From medical device developing regulatory strategy documents to facilitating market entry through our authorized representative and importer services, we ensure a smooth and efficient compliance process. Partner with AF Pharma as your Authorized Representative today and benefit from our competitive prices, global communication network, and proven track record in medical device regulatory compliance. We help companies to navigate the Medical Device Regulations and gain the confidence to navigate complex regulations with ease and unlock new opportunities in international markets. Contact us now to get started on your regulatory compliance journey.

AF Pharma Service: Your trusted experts in compliance for the Medical Device Regulations.

Ask for EU Authorized Representative (EC Rep), UK Responsible Person (UKRP) or FDA US Agent quotation. Do not forget, we provide Person Responsible for the Regulatory Compliance (PRRC).

Let's start working together today!

Medica Device Registation

Authorized Representative (EC Rep)
UK Responsible Person (UKRP)
FDA US Agent

We are MDR / IVDR Sponsors Certified European Authorized Representative (EC REP) for the registration of medical devices, in vitro diagnostic medical devices, machinery, cosmetics and more under the European Competent Authorities. With the new EU Regulations in force, every non-EU manufacturer needs to appoint an EU Authorized Representative.

As a leading provider of medical device regulatory services, AF Pharma offers unmatched expertise and support to navigate the complex landscape of medical device regulations worldwide. Our team of EU MDR 2017/745 / IVDR 2017/746 Authorized Representatives (also known as EC Reps or EUARs) excels in medical device submissions and agency responses, ensuring compliance with international standards. Leverage our extensive experience and expertise as EU Authorized Representatives to register and market your medical devices in the European market. Our experience shows that we are the best support for any medical device manufacturer is to register, import and sell their medical devices in the European market. We are MDR / IVDR Sponsors certified for acting as Authorized Representative and we provide services for medical device manufacturers with MDR, IVDR, MDD and IVDR certifications.

In the United Kingdom, we are registered and certified by the MHRA to act as a UK Responsible Person (UKRP). Also, we have experience in obtaining the new UKCA mark, and we can help medical device companies to obtain the medical device certifications throughout the UK medical device path. Being a UK Responsible Person (UKRP) entails certain obligations for UKRPs, we have been certified and our experience supports us.

AF Pharma Service is a trusted name in the field of medical device regulations compliance, known for its exceptional expertise as specialists consultants. With a deep understanding of the ever-evolving medical device and pharmaceutical landscape, AF Pharma is committed to ensuring that medical device companies navigate the complex regulatory environment with confidence and precision. Our team of dedicated consultants possesses an extensive knowledge of global medical device regulations, guidelines, and industry best practices, enabling them to provide comprehensive solutions tailored to each client's specific needs.

Partner with AF Pharma Service and benefit from our proven track record in helping medical device manufacturers overcome regulatory challenges and achieve successful market access. Contact us today to streamline your processes and optimize your medical device regulations compliance efforts.

Don´t forget! We are certified in Machinery Directive 2006/42/EC!

WE ARE YOUR PERFECT MATCH

Contact us for a quotation as your EU Authorized Representative / UK Responsible Person (UKRP) / US Agent for medical devices and more

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EU Authorized Representative

Medical Device Regulatory Services

EU Authorized Representative - EC Rep
MDR / IVDR Registrations

The Authorized Representative is also known as CE REP, EU Sponsor or Auth Rep, and it is a legal person which acts on behalf of the medical device manufacturer for the European Authorities. The European Authorized Representatives is a mandatory economic operator for every Non-EU medical device, machinery (under Machinery Directive 2006/42/EC) and also for cosmetics manufacturers.

In the case of the medical devices manufacturers, with the new MDR (Medical Device Regulation 2017/745) and IVDR (InVitro Diagnostic Regulation 2017/746) implemented, and the MDD grace periods implemented, choosing the correct EU Authorized Representative becomes the main task for any medical device manufacturer.

AF Pharma Service Europe is registered under the MDR (Medical Device Regulation 2017/745) and IVDR (InVitro Diagnostic Regulation 2017/746) in the EU Health Authorities and in EUDAMED to act as EU Authorized Representatives. Also, we are approved for working with for medical devices, machinery, cosmetics and nutraceuticals.

UK Responsible Person

UK Responsible Person - UKRP
MHRA Registrations

The UK Responsible Person (also known as UKRP, UK Representative, UKCA Representative or UK Authorized Representative) is a mandatory economic operator for medical devices, machinery, cosmetics and other manufacturers outside the UK.

We are registered with the UK to act as the UK Responsible Person for Medical Devices, Machinery, Cosmetics and Nutraceuticals. MHRA provided us the certification under the UK Medical Device Regulation 2002.

FDA
US Agent
FDA Registrations

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment. The U.S. agent cannot use just an answering service. The US Agent must be available to answer the phone or have an employee available to answer the phone during normal business hours, also the US Agent can act for medical devices, cosmetics and more.

The US Agent must be able to provide you information about 510k registrations, Cosmetics Voluntary registrations, and Small Business Registration program.