EU Authorised Representative
Your Taylored Gateway to the EU Market
Navigating the complexities of the European market can be a daunting task, especially when it comes to complying with regulatory requirements.
As your EU Authorised Representative, Taylored Consultancy serves as your gateway to the EU market ensuring your products meet all necessary Medical Device Regulations.
Appointing an EU Authorised Representative is essential for non-EU manufacturers to ensure that all necessary documentation, including the EU declaration of conformity and technical documentation, is accurately prepared and maintained. For those looking to import medical devices into the EU, an authorised representative is mandatory.
By acting as your liaison with European authorities and managing all regulatory communications, Taylored Consultancy helps you to bring your medical devices into the EU market smoothly and efficiently.
We understand the complexities of navigating the European marketplace
Appointing an EU Authorised Representative is required for medical device manufacturers who are looking to import their products into the EU. An authorised rep ensures compliance with EU regulations, acts as your liaison, managing interactions with relevant European authorities and ensuring that all necessary documentation is correct.
REGULATORY REQUIREMENTS
The role of an EU Authorised Representative also involves reducing risk. We help you identify that your products meet EU standards, helping prevent potential legal and financial repercussions that could arise from non-compliance.
MITIGATING RISK
Having an EU Authorised Representative is not just a regulatory formality; it’s a strategic advantage for when you are ready to access the market. By making sure your products are compliant, we help you build trust with distributors and customers.
MARKET ACCESS
Once your product is on the market, we are here to ensure that your medical devices remain compliant. Our role allows us to respond to any requests from authorities, provide necessary documentation, and demonstrate conformity on your behalf.
ONGOING COMPLIANCE
What Our Clients Say
I am writing to wholeheartedly recommend Bethany, whose collaboration has not only been immensely valuable but truly transformative in our recent project. Bethany stands out as a beacon of professionalism, demonstrating a level of dedication and expertise that is rare and highly commendable. Her dynamic approach to challenges is both refreshing and effective, allowing our team to navigate complexities with confidence. Bethany possesses a unique ability to anticipate the needs of a project, taking informed, proactive steps that ensure success. This foresight, combined with her willingness to take initiative in key decision-making processes, has significantly contributed to our achievements. I highly recommend Bethany, without hesitation!
Sven, Managing Director
Taylored Consultancy were clear with direction, great at communicating, and easy to get in contact with.
Jan, Director
Working with Taylored Consultancy has brought an additional layer of expertise to our business. Collaborating with Bethany has allowed us to remain compliant, whilst offering practical solutions that help us to clearly and effectively communicate with our customers. From formulations through to consumer-facing claims, Bethany remains a joy to work with, always on hand to expertly offer tailored regulatory advice.
Heather, Head of Marketing
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UK Responsible Person
EU Authorised Representative
UK MDR Compliance
Regulatory Strategy
Formulation Review
Technical File Review
Claims Review
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Medical Devices
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