Authorized Representative (EC Rep) and UKRP
most frequently asked questions (FAQ)
Do I need both an EU Authorized representative (EC Rep) and a UK Responsible Person (UKRP)?
This is one of the most frequently asked questions (FAQ). From 16 July 2021 you will need to appoint an EU authorized representative, also called EC Rep or EAR, based in the EU, EEA or Northern Ireland if you sell certain goods without using an importer or fulfilment service provider. For example if you sell online and ship directly to the end user.
From January 2021, that was also requested for UK, called UK Responsible Person (UKRP).
What is an EU authorized representative under the MDR EU 2017/745?
“'authorized representative' (or EC Rep) means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations […]
Do I need an Authorized representative in the UK?
The UK Authorized Representative is called UK Responsible Person (UKRP) in the UK. For goods sold in Great Britain (GB – England, Wales, Scotland), a EU, GB or NI address may continue to be used until 30 September 2022. From 1 October 2022, a UK address must be used. For goods sold in the EU, an EU address is required on pack from 1 January, 2021.
For this reason, if you want to place goods in the UK, you must appoint a UKRP. And if you want to place goods in the EU you need an EU authorized representative.
We are proud to cover both, acting as EU Authorized Representative (EC Rep) and UK Responsible Person (UKRP).
What is a European Authorized Representative (EC Rep)?
The role of a European Authorized Representative (EC Rep) is both varied and challenging. The main duties include, but are not limited to, the following:
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Providing a registered address within the European Union.
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Keeping all technical documentation available for inspection by the European Authorities.
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Completing notifications.
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Completing any registrations to national databases.
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Taking care of any incident reporting.
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Representing the manufacturer towards the European Commission, Authorities and Notified Bodies.
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Safeguarding and ensuring compliance with MDR/IVDR.
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Consulting on European Regulations.
What is EU Authorized Representative (EC Rep) certificate?
Foreign Medical Device manufacturers who do not have a physical location in Europe must appoint a European Authorized Representative (also referred as EC Rep or EAR). The European Authorized Representative must be based in any member countries of the European Union.
What a United Kingdom Responsible Person (UKRP) is?
After the UK left the European Union on December 31st, 2020, the UK has defined two different legal frameworks for Great Britain and Northern Ireland.
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Great Britain will recognize the EU CE Marking until June 30th 2023. The new UKCA marking according to the UK MDR 2002 regulations, although already available, will be mandatory as of July 1st 2023 in GB.
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Northern Ireland will keep in line with the EU, meaning that the CE Marking will fully apply. However, a new marking has been introduced: CE UKNI according to the EU Legal Framework but only recognized in NI
The UK Responsible Person (UKRP) is who will manage and make the registrations for all the non UK manufacturers in UK.
Where can I find the original documents for MDR 2017/745 and IVDR 2017/746?
Please, click in the links we are providing:
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MDR
https://eur-lex.europa.eu/legal-content/ES/ALL/?uri=celex:32017R0745
IVDR
https://eur-lex.europa.eu/legal-content/ES/TXT/?uri=CELEX%3A32017R0746
Machinery
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Consultancy services
At AF Pharma Consultancy, we understand the unique challenges faced by medical device manufacturers. With our expert guidance and comprehensive consulting services, we help you navigate complex regulatory landscapes, streamline processes, and achieve excellence in the medical device industry.
The questions mentioned above are the most typical, however there may be some new ones, and we invite you to consult us.
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Quality Management System (QMS) Consulting services:
Our experienced consultants work closely with your team to design and implement a customized QMS tailored to your specific needs. We ensure compliance with ISO 13485 and other relevant standards, empowering you to deliver high-quality products and meet regulatory requirements.
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Regulatory Compliance Support:
Staying up to date with ever-changing regulations can be daunting. Our consultants are well-versed in FDA, CE, and global standards, providing comprehensive support for regulatory submissions, audits, risk management, and post-market surveillance. We help you navigate compliance challenges and ensure your medical devices meet all necessary regulatory criteria.
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ISO 13485 Certification:
ISO 13485 certification is a significant milestone for medical device manufacturers. Our experts guide you through the certification process, assisting with documentation, internal audits, and readiness assessments. By aligning your organization with ISO 13485 requirements, we enhance your credibility and open doors to domestic and international markets.
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Process Improvement and Optimization:
Efficient processes are key to achieving operational excellence. Our expert consultants analyze your current processes, identifying areas for improvement and optimization. By streamlining workflows and reducing inefficiencies, we help you maximize productivity, minimize costs, and enhance overall business performance.
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Customized Solutions for the Medical Device Success:
At AF Pharma Consultancy, we recognize that every client has unique needs and goals. Our consulting services are tailored to your specific requirements, ensuring personalized solutions that address your challenges effectively. We are dedicated to your success and work closely with you at every step of the consulting journey.