UK & EU Responsible Person Services
for
Medical Devices & Cosmetics
Expert UK & EU Compliance Solutions for Seamless Market Entry
Are you looking to sell medical devices or cosmetic products in the UK or EU? Regulatory compliance is a legal requirement, and having an EU Authorised Representative (EU AR) or a UK Responsible Person (UKRP) is essential.
At Eomi Consultancy, we provide expert UK & EU Responsible Person services to ensure your products meet all regulatory requirements, making market entry smooth, fast, and hassle-free.
Navigating the intricacies of the European market can be challenging, particularly when it comes to adhering to regulatory standards.
As your trusted EU Authorised Representative, Eomi Consultancy provides the essential support needed to ensure your medical devices comply with all relevant EU regulations. We act as your bridge to the EU market, ensuring that your products meet the necessary Medical Device Regulations and facilitating a smooth entry process.
For non-EU manufacturers, appointing an EU Authorised Representative is crucial. We ensure that all required documentation—such as the EU declaration of conformity and technical files—are accurately prepared, maintained, and submitted. This is a mandatory step for those looking to import medical devices into the EU.
By managing regulatory communications and liaising with European authorities on your behalf, Eomi Consultancy streamlines the process, making your medical device market launch in the EU efficient and hassle-free
Simplifying Your Path to Compliance with Expert Medical Device Guidance
REGULATORY REQUIREMENTS
Appointing an EU Authorised Representative is a critical requirement for medical device manufacturers seeking to import their products into the EU. An authorised representative ensures your products comply with EU regulations, serves as your liaison with European authorities, and manages all necessary documentation, ensuring everything is accurate and up to standard.
MITIGATING RISK
The role of an EU Authorised Representative goes beyond compliance—it also helps reduce risk. At Eomi Consultancy, we ensure your products meet EU standards, minimizing the risk of legal and financial consequences that could arise from non-compliance. Our expertise helps you avoid costly setbacks, ensuring a smooth market entry.
REGULATORY REQUIREMENTS
For medical device manufacturers looking to enter the EU market, appointing an EU Authorised Representative is essential. This role ensures that your products fully comply with EU regulations. Acting as your intermediary, an authorised representative manages all communications with European authorities and guarantees that your documentation is thorough, accurate, and in line with regulatory requirements.
ONGOING COMPLIANCE
After your product reaches the market, we stay by your side to ensure ongoing compliance. Acting as your EU Authorised Representative, we manage communications with authorities, supply any necessary documentation, and confirm your product’s compliance with EU standards, so you can focus on your business with confidence.